An interventional study of VenaSeal™ System and Endothermal Ablation (ETA) in Venous Reflux, sponsored by Medtronic Endovascular. Terminated at 32 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Medtronic Endovascular · Not applicable, Interventional, and Treatment
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease
The study is designed with two randomized studies and one single arm study.
Two randomized studies are for CEAP 2-5 subjects:
The single arm study is for CEAP 6 subjects with active venous leg ulcers (VLU):
1. VLU Study
Eligibility for treatment:
Exclusion Criteria:
Instructions for Use (IFU) contraindications:
CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA
Device: VenaSeal™ System
CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA
Device: Endothermal Ablation (ETA)
CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping
Device: VenaSeal™ System
CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping
Procedure: Surgical Stripping
CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System
Device: VenaSeal™ System
The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Also known as: Endovenous laser ablation (EVLA), Radiofrequency ablation (RFA)
Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.
Time frame: 30 days
Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.
Time frame: 30 days
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.
Time frame: 30 days
Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.
Time frame: 30 days
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.
Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
Time frame: Post Index procedure, on the day of the procedure immediately following treatment
Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.
Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
Time frame: Post Index procedure, on the day of the procedure immediately following treatment
Single Arm Venous Leg Ulcer (VLU) Study: Primary Endpoint: Time to Ulcer Healing, Calculated Through Healing Confirmation and Verified by an Independent Core Laboratory Through 12 Months.
Time to ulcer healing reported by using the cumulative incidence probability estimate of the event happening at 12 months, expressed as a percentage. The data values below represent the cumulative incidence probability as a percentage of participants with ulcer healing through 12 months.
Time frame: 12 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.
Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.
Time frame: 6 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.
Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.
Time frame: 6 months
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.
Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.
Time frame: 6 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.
Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.
Time frame: 30 days
Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.
Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.
Time frame: 30 days
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.
Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.
Time frame: 30 days
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months.
For subjects treated with the VenaSeal™ system or ETA it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12, 24, 36, 48 and 60 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure at 30 days and 12, 24, 36, 48 and 60 months.
Time frame: 30 days and 12, 24, 36, 48 and 60 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12 Months.
Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.
Time frame: 30 days, 12 months
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months.
For subjects treated with the VenaSeal™ system it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 12 months, 24 months, 36 months, 48 months and 60 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure tat 30 days, 12 months, 24 months, 36 months, 48 months and 60 months
Time frame: 30 days, 12 months, 24 months, 36 months, 48 months and 60 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months.
For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, and 6, 12, 24, 36, 48 and 60 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, and 6, 12, 24, 36, 48 and 60 months.
Time frame: 30 days, and 6, 12, 24, 36, 48 and 60 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months.
Anatomic closure of target superficial truncal vein defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.
Time frame: 30 days, 6, 12 months
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months.
For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, and 6, 12, 24, 36, 48 and 60 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure at 30 days, and 6, 12, 24, 36, 48 and 60 months.
Time frame: 30 days, and 6, 12, 24, 36, 48 and 60 months.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.
For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.
Time frame: Post Index procedure, on the day of the procedure immediately following treatment
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.
Defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual vein after surgical stripping procedures.
Time frame: Post Index procedure, on the day of the procedure immediately following treatment
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.
For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.
Time frame: Post Index procedure, on the day of the procedure immediately following treatment
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months, Assessed at Each Follow-up Visit.
Time frame: 12 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months, Assessed at Each Follow-up Visit.
Time frame: 60 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months.
As measured by the time between the index procedure and the first reintervention procedure. Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 12 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 12 months.
Time frame: 12 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.
Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT) or endovenous heat induced thrombosis (EHIT), Symptomatic deep vein thrombosis (DVT) events.
Time frame: 12 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.
Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.
Time frame: 12 months
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.
Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.
Time frame: 12 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Additional Events Evaluated Through 12 Months.
Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).
Time frame: 12 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.
Time frame: 12 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.
Time frame: 12 months
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.
Time frame: 12 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD.
Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 12 months.
Time frame: 12 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months.
Time frame: 12 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.
Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.
Time frame: 30 days
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.
Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.
Time frame: 30 days
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.
Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.
Time frame: 30 days
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.
Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.
Time frame: Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.
Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.
Time frame: Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.
Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.
Time frame: Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 7 and 30 days, and at 6, 12, 24, 36 and 60 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12 Months Compared to Baseline.
Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 7 and 30 days, and at 6 and 12 months
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 7 and 30 days, and at 6, 12, 24, 36 and 60 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Aberdeen Varicose Vein Questionnaire (AVVQ) Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and at 6, 12, 24, 36, 48 and 60 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6 and 12 Months Compared to Baseline.
The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and 6 and 12 months
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and at 6, 12, 24, 36 and 60 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline.
EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and 6, 12, 24, 36, 48 and 60 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6 and 12 Months Compared to Baseline.
EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and 6 and 12 months
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline.
EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and 6, 12, 24, 36, 48 and 60 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.
The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and 6 and 12 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.
The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and 6 and 12 months
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.
The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.
Time frame: 30 days, and 6 and 12 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
The Generic VenousDQOL score was calculated as the average of the Quality of Life scores measured on an interval from +3 (Excellent) to -3 (Extremely Bad). The outcome measure data reports the responses at the different time points compared to baseline.
Time frame: 30 days, and 6, 12, 24, 36, 48, and 60 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline.
The Generic VenousDQOL score was calculated as the average of the Quality of Life scores measured on an interval from +3 (Excellent) to -3 (Extremely Bad). The outcome measure data reports the responses at the different time points compared to baseline.
Time frame: 30 days, and 6, 12 months
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.
The Generic VenousDQOL score was calculated as the average of the Quality of Life scores measured on an interval from +3 (Excellent) to -3 (Extremely Bad). The outcome measure data reports the responses at the different time points compared to baseline.
Time frame: 30 days, and 6, 12, 24, 36, 48, and 60 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.
Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).
Time frame: Post-index procedure, on the day of the procedure immediately following treatment
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.
Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).
Time frame: Post-index procedure, on the day of the procedure immediately following treatment
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.
Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).
Time frame: Post-index procedure, on the day of the procedure immediately following treatment
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.
Time frame: 30 days
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Patient Satisfaction as Measured by a Validated Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.
Time frame: 30 days
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Target Vein at the Time of Index Procedure as Measured by the Percentage of Target Veins Successfully Treated.
Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
Time frame: Post-index procedure, on the day of the procedure immediately following treatment
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months, Assessed at Each Follow-up Visit.
Time frame: 60 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD.
Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 60 months
Time frame: 60 months
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD.
Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 60 months.
Time frame: 60 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 60 Months.
Time frame: 60 months
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 60 Months.
Time frame: 60 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months.
As measured by the time between the index procedure and the first reintervention procedure. Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 60 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 60 months.
Time frame: 60 months
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months.
As measured by the time between the index procedure and the first reintervention procedure. Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 60 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 60 months.
Time frame: 60 months
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Time to Ulcer Recurrence on the Target Limb Following Ulcer Healing Through 60 Months.
Time to ulcer recurrence reported by using the cumulative incidence probability estimate of the event happening at 60 months, expressed as a percentage. Ulcer recurrence could only occur after the initial ulcer had completely healed.
Time frame: 60 months
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Ulcer Free Time, Calculated as Days Between Initial Ulcer Healing and First Ulcer Recurrence, as Applicable, Through 60 Months.
As measured by the time between initial ulcer healing and the first ulcer recurrence.
Time frame: 60 months
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Ulcer Healing Rate, as Measured by the Percentage of the Ulcer Area Healed, Through 24 Months.
Ulcer healing rate, as measured by the percentage of the ulcer area healed, according to an independent core laboratory through 24 months or until ulcer healing has been confirmed. This was assessed by overall number of wound care utilizations, and also by different wound care treatments subtypes.
Time frame: 24 months
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Healthcare Utilization and Routine Wound Care Treatments Between Study Visits Through 60 Months.
Determined by the number of ulcer wound care treatments utilized between study visits through 60 months.
Time frame: 60 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Additional Events Evaluated Through 60 Months.
Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).
Time frame: 60 Months
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Additional Events Evaluated Through 60 Months.
Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).
Time frame: 60 Months
| Milestone | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|---|---|---|---|
| Started | 136 | 139 | 53 | 53 | 125 |
| 7 days | 131 | 126 | 48 | 43 | 125 |
| 30 days | 131 | 123 | 46 | 43 | 123 |
| 6 months | 129 | 120 | 46 | 42 | 108 |
| 12 months | 125 | 117 | 45 | 42 | 99 |
| 24 months | 113 | 110 | 0 | 0 | 91 |
| 36 months | 105 | 104 | 0 | 0 | 47 |
| 48 months | 41 | 45 | 0 | 0 | 11 |
| 60 months | 4 | 3 | 0 | 0 | 1 |
| Completed | 2 | 3 | 40 | 38 | 1 |
| Not completed | 134 | 136 | 13 | 15 | 124 |
| Withdrew: Physician decision | 0 | 2 | 1 | 0 | 5 |
| Withdrew: Withdrawal by subject | 18 | 16 | 3 | 9 | 9 |
| Withdrew: Procedure not attempted | 0 | 2 | 1 | 0 | 0 |
| Withdrew: Other exit | 1 | 3 | 8 | 6 | 0 |
| Withdrew: Death | 0 | 1 | 0 | 0 | 18 |
| Withdrew: Lost to follow-up | 13 | 11 | 0 | 0 | 11 |
| Withdrew: Study termination | 102 | 101 | 0 | 0 | 81 |
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.
| score on a scale | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days. | 30.8 ± 4.22 | 29.6 ± 4.73 |
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.
| score on a scale | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days. | 29.3 ± 4.94 | 25.0 ± 6.24 |
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.
| score on a scale | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days. | 31.8 ± 5.12 | 32.1 ± 4.95 |
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.
| score on a scale | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days. | 30.1 ± 6.39 | 28.3 ± 5.58 |
Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
| % of vein length | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure. | 92.4 ± 13.40 | 91.1 ± 11.85 |
Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
| % of vein length | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure. | 69.9 ± 19.93 | 68.2 ± 25.82 |
Time to ulcer healing reported by using the cumulative incidence probability estimate of the event happening at 12 months, expressed as a percentage. The data values below represent the cumulative incidence probability as a percentage of participants with ulcer healing through 12 months.
| percentage probability | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Single Arm Venous Leg Ulcer (VLU) Study: Primary Endpoint: Time to Ulcer Healing, Calculated Through Healing Confirmation and Verified by an Independent Core Laboratory Through 12 Months. | 85.2 |
Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.
| percentage probability | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months. | 93.9 | 93.5 |
Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.
| percentage probability | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months. | 97.9 | 92.9 |
Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.
| percentage probability | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months. | 87.3 |
Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.
| percentage probability | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Time to Return to Work as Reported by the Patient. | 97.9 | 97.6 |
Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.
| percentage probability | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient. | 89.0 | 76.5 |
Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.
| percentage probability | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient. | 85.7 |
For subjects treated with the VenaSeal™ system or ETA it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12, 24, 36, 48 and 60 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure at 30 days and 12, 24, 36, 48 and 60 months.
| percentage probability | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| 30 days | 95.4 | 95.2 |
| 12 months | 86.6 | 89.3 |
| 24 months | 84.0 | 84.7 |
| 36 months | 84.0 | 80.8 |
| 48 months | 82.9 | 78.9 |
| 60 months | 82.9 | — |
Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.
| percentage probability | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| 30 days | 97.9 | 97.7 |
| 12 months | 95.7 | 92.9 |
For subjects treated with the VenaSeal™ system it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 12 months, 24 months, 36 months, 48 months and 60 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure tat 30 days, 12 months, 24 months, 36 months, 48 months and 60 months
| percentage probability | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| 30 days | 91.9 |
| 12 months | 82.3 |
| 24 months | 78.0 |
| 36 months | 75.1 |
| 48 months | 69.0 |
For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, and 6, 12, 24, 36, 48 and 60 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, and 6, 12, 24, 36, 48 and 60 months.
| percentage probability | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| 30 days | 95.7 | 94.6 |
| 6 months | 93.5 | 93.1 |
| 12 months | 86.6 | 89.0 |
| 24 Months | 84.2 | 84.7 |
| 36 months | 84.2 | 81.0 |
| 48 months | 83.2 | 78.3 |
| 60 months | 83.2 | — |
Anatomic closure of target superficial truncal vein defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.
| percentage probability | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| 30 days | 98.0 | 97.8 |
| 6 months | 98.0 | 93.2 |
| 12 months | 96.0 | 93.2 |
For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, and 6, 12, 24, 36, 48 and 60 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure at 30 days, and 6, 12, 24, 36, 48 and 60 months.
| percentage probability | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| 30 days | 93.6 |
| 6 months | 89.1 |
| 12 months | 85.2 |
| 24 months | 81.0 |
| 36 months | 78.7 |
| 48 months | 73.8 |
For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.
| Target Veins | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure. | 136 | 129 |
Defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual vein after surgical stripping procedures.
| Target Veins | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure. | 49 | 44 |
For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.
| Target Veins | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure. | 147 |
| reintervention per vein-years | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months, Assessed at Each Follow-up Visit. | 0.06 | 0 |
| reintervention per vein-years | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months, Assessed at Each Follow-up Visit. | 0.014 | 0.002 |
As measured by the time between the index procedure and the first reintervention procedure. Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 12 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 12 months.
| percentage probability | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months. | 93.1 | 100 |
Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT) or endovenous heat induced thrombosis (EHIT), Symptomatic deep vein thrombosis (DVT) events.
| Participants | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| Hypersensitivity to VenaSeal™ adhesive | 8 | 0 |
| Phlebitis | 12 | 4 |
| Granuloma | 1 | 0 |
| EGIT/EHIT | 1 | 5 |
| DVT | 0 | 1 |
Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.
| Participants | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| Hypersensitivity to VenaSeal™ adhesive | 6 | 0 |
| Phlebitis | 2 | 1 |
| Granuloma | 0 | 0 |
| EGIT | 0 | 0 |
| DVT | 0 | 0 |
Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.
| Participants | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Hypersensitivity to VenaSeal™ adhesive | 1 |
| Phlebitis | 13 |
| Granuloma | 2 |
| EGIT | 3 |
| DVT | 2 |
Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).
| Participants | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| Symptomatic pulmonary embolism (PE) | 0 | 0 |
| Serious adverse events (SAEs) | 1 | 2 |
| adjunctive treatment per vein-years | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| Phlebectomy | 0.02 | 0.01 |
| Sclerotherapy | 0.1 | 0.08 |
| adjunctive treatment per vein-years | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| Phlebectomy | 0.07 | 0 |
| Sclerotherapy | 0.07 | 0.02 |
| adjunctive treatment per vein-years | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Sclerotherapy | 0.12 |
| Phlebectomy | 0 |
Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 12 months.
| services utilized per person-years | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| Inpatient Visits | 0.0210 | 0.0228 |
| Hospital Outpatient Visits | 0.4409 | 0.1596 |
| Clinic Visits | 0.0840 | 0.1824 |
| Outpatient ER Visits | 0.0210 | 0.0228 |
| Participants | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| Diagnostic Tests Performed: Computed Tomographic Venography | 0 | 0 |
| Diagnostic Tests Performed: DUS | 4 | 2 |
| Diagnostic Tests Performed: Intravascular Ultrasound | 0 | 0 |
| Diagnostic Tests Performed: Magnetic Resonance Venography | 0 | 0 |
| Diagnostic Tests Performed: Venogram | 0 | 0 |
| Diagnostic Tests Performed: Other | 1 | 0 |
| Actions Taken: Medication Change | 9 | 1 |
| Actions Taken: Intervention Involving Target Limb/Vein | 2 | 2 |
| Hospitalization | 1 | 1 |
| Other Actions | 1 | 1 |
Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.
| percentage probability | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients. | 98.5 | 96.8 |
Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.
| percentage probability | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients. | 95.8 | 93.0 |
Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.
| percentage probability | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients. | 80.9 |
Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.
| score on a scale | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| Intra-procedure | 2.0 ± 2.13 | 2.7 ± 2.41 |
| Post-procedure | 1.1 ± 1.35 | 1.2 ± 1.73 |
| 7 days | 1.1 ± 1.58 | 1.0 ± 1.40 |
| 30 days | 0.6 ± 1.05 | 0.7 ± 1.23 |
Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.
| score on a scale | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| Intra-procedure | 1.6 ± 2.25 | 0.8 ± 1.95 |
| Post-procedure | 1.5 ± 1.97 | 0.9 ± 2.00 |
| 7 days | 2.1 ± 2.24 | 2.2 ± 2.10 |
| 30 days | 1.5 ± 1.92 | 2.3 ± 2.39 |
Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.
| score on a scale | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Intra-procedure | 3.6 ± 2.88 |
| Post-procedure | 2.3 ± 2.36 |
| 7 days | 2.1 ± 2.27 |
| 30 days | 1.8 ± 2.32 |
Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames.
| score on a scale | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| 7 days change from baseline | -2.2 ± 2.76 | -1.4 ± 2.48 |
| 30 days change from baseline | -3.4 ± 2.63 | -3.0 ± 2.72 |
| 6 months change from baseline | -4.3 ± 2.53 | -3.6 ± 2.83 |
| 12 months change from baseline | -3.9 ± 2.71 | -3.8 ± 2.95 |
| 24 months change from baseline | -4.0 ± 2.73 | -3.8 ± 2.62 |
| 36 months change from baseline | -3.9 ± 2.53 | -3.8 ± 2.48 |
| 48 months change from baseline | -4.6 ± 3.33 | -4.8 ± 2.90 |
| 60 months change from baseline | -4.5 ± 0.71 | -4.0 ± 1.00 |
Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames.
| score on a scale | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| 7 days change from baseline | -2.4 ± 1.90 | -1.6 ± 2.63 |
| 30 days change from baseline | -3.2 ± 1.78 | -2.2 ± 2.45 |
| 6 months change from baseline | -3.4 ± 1.79 | -3.0 ± 2.72 |
| 12 months change from baseline | -3.6 ± 2.16 | -3.6 ± 2.56 |
Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames.
| score on a scale | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| 7 days change from baseline | -3.3 ± 3.95 |
| 30 days change from baseline | -5.6 ± 5.00 |
| 6 months change from baseline | -8.7 ± 5.27 |
| 12 months change from baseline | -9.0 ± 5.44 |
| 24 months change from baseline | -8.9 ± 5.38 |
| 36 months change from baseline | -9.5 ± 6.18 |
| 48 months change from baseline | -10.4 ± 7.49 |
| 60 months change from baseline | -16.0 ± NA |
The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames.
| score on a scale | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| 30 days change from baseline | -5.4 ± 7.88 | -2.4 ± 8.01 |
| 6 months change from baseline | -7.8 ± 7.77 | -5.9 ± 8.75 |
| 12 months change from baseline | -8.0 ± 7.68 | -6.4 ± 10.05 |
| 24 months change from baseline | -8.4 ± 8.52 | -6.8 ± 8.26 |
| 36 months change from baseline | -8.7 ± 7.90 | -6.1 ± 9.34 |
| 48 months change from baseline | -8.8 ± 10.23 | -8.3 ± 10.46 |
| 60 months change from baseline | -5.0 ± 5.29 | -11.3 ± 12.44 |
The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames.
| score on a scale | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| 30 days change from baseline | -4.7 ± 5.94 | -1.0 ± 8.89 |
| 6 months change from baseline | -7.0 ± 6.26 | -7.7 ± 7.97 |
| 12 months change from baseline | -7.3 ± 6.13 | -8.8 ± 6.62 |
The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames.
| score on a scale | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| 30 days change from baseline | -8.1 ± 13.66 |
| 6 months change from baseline | -13.4 ± 14.40 |
| 12 months change from baseline | -15.4 ± 15.21 |
| 24 months change from baseline | -12.0 ± 17.12 |
| 36 months change from baseline | -12.7 ± 15.87 |
| 48 months change from baseline | -12.9 ± 18.96 |
| 60 months change from baseline | -25.9 ± NA |
EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.
| score on a scale | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| 30 days change from baseline | 0.10 ± 0.14 | 0.08 ± 0.15 |
| 6 months change from baseline | 0.09 ± 0.14 | 0.08 ± 0.18 |
| 12 months change from baseline | 0.08 ± 0.16 | 0.08 ± 0.15 |
| 24 months change from baseline | 0.08 ± 0.15 | 0.05 ± 0.15 |
| 36 months change from baseline | 0.09 ± 0.13 | 0.07 ± 0.14 |
| 48 months change from baseline | 0.12 ± 0.16 | 0.11 ± 0.16 |
| 60 months change from baseline | 0.09 ± 0.13 | 0.07 ± 0.08 |
EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.
| score on a scale | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| 30 days change from baseline | 0.12 ± 0.19 | 0.15 ± 0.24 |
| 6 months change from baseline | 0.13 ± 0.19 | 0.13 ± 0.24 |
| 12 months change from baseline | 0.12 ± 0.22 | 0.14 ± 0.28 |
EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.
| score on a scale | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| 30 days change from baseline | 0.1 ± 0.24 |
| 6 months change from baseline | 0.1 ± 0.25 |
| 12 months change from baseline | 0.2 ± 0.25 |
| 24 months change from baseline | 0.1 ± 0.33 |
| 36 months change from baseline | 0.1 ± 0.24 |
| 48 months change from baseline | -0.1 ± 0.33 |
| 60 months change from baseline | 0.2 ± NA |
The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.
| score on a scale | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| Physical Scale 30 days change from baseline | 2.5 ± 5.88 | 1.8 ± 5.43 |
| Mental Scale 30 days change from baseline | 2.1 ± 9.35 | 0.9 ± 8.89 |
| Physical Scale 6 months change from baseline | 2.9 ± 6.62 | 2.1 ± 5.50 |
| Mental Scale 6 months change from baseline | 2.4 ± 9.77 | 1.3 ± 8.41 |
| Physical Scale 12 months change from baseline | 3.1 ± 6.85 | 1.8 ± 5.90 |
| Mental Scale 12 months change from baseline | 2.5 ± 8.65 | 1.0 ± 8.27 |
The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.
| score on a scale | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| Physical Scale 30 days change from baseline | 3.0 ± 6.50 | 0.5 ± 6.42 |
| Mental Scale 30 days change from baseline | 3.4 ± 9.18 | 2.1 ± 11.05 |
| Physical Scale 6 months change from baseline | 3.2 ± 6.39 | 1.4 ± 6.15 |
| Mental Scale 6 months change from baseline | 3.4 ± 8.21 | 1.6 ± 8.23 |
| Physical Scale 12 months change from baseline | 3.7 ± 7.71 | 2.9 ± 7.08 |
| Mental Scale 12 months change from baseline | 1.8 ± 11.55 | 0.2 ± 9.71 |
The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.
| score on a scale | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Physical Scale 30 days change from baseline | 2.20 ± 7.17 |
| Mental Scale 30 days change from baseline | 3.60 ± 12.13 |
| Physical Scale 6 months change from baseline | 2.86 ± 7.77 |
| Mental Scale 6 months change from baseline | 5.82 ± 10.67 |
| Physical Scale 12 months change from baseline | 3.80 ± 8.23 |
| Mental Scale 12 months change from baseline | 5.81 ± 11.63 |
The Generic VenousDQOL score was calculated as the average of the Quality of Life scores measured on an interval from +3 (Excellent) to -3 (Extremely Bad). The outcome measure data reports the responses at the different time points compared to baseline.
| score on a scale | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| 30 days change from baseline | 0.3 ± 1.01 | 0.2 ± 0.97 |
| 6 months change from baseline | 0.4 ± 0.96 | 0.4 ± 1.10 |
| 12 months change from baseline | 0.4 ± 0.98 | 0.2 ± 1.02 |
| 24 months change from baseline | 0.1 ± 1.08 | 0.1 ± 0.96 |
| 36 months change from baseline | 0.2 ± 1.11 | 0.2 ± 0.90 |
| 48 months change from baseline | 0.1 ± 1.29 | 0.1 ± 0.96 |
| 60 months change from baseline | 1.0 ± NA | — |
The Generic VenousDQOL score was calculated as the average of the Quality of Life scores measured on an interval from +3 (Excellent) to -3 (Extremely Bad). The outcome measure data reports the responses at the different time points compared to baseline.
| score on a scale | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| 30 days change from baseline | 0.5 ± 1.01 | 0.6 ± 1.36 |
| 6 months change from baseline | 0.6 ± 1.24 | 0.5 ± 1.38 |
| 12 months change from baseline | 0.5 ± 1.32 | 0.7 ± 1.71 |
The Generic VenousDQOL score was calculated as the average of the Quality of Life scores measured on an interval from +3 (Excellent) to -3 (Extremely Bad). The outcome measure data reports the responses at the different time points compared to baseline.
| score on a scale | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| 30 days change from baseline | 0.4 ± 1.10 |
| 6 months change from baseline | 0.4 ± 1.34 |
| 12 months change from baseline | 0.4 ± 1.27 |
| 24 months change from baseline | 0.4 ± 1.28 |
| 36 months change from baseline | 0.4 ± 1.22 |
| 48 months change from baseline | -0.1 ± 0.78 |
Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).
| Participants | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| Physician Satisfaction with Procedure: Extremely Satisfied | 77 | 71 |
| Physician Satisfaction with Procedure: Satisfied | 49 | 52 |
| Physician Satisfaction with Procedure: Neutral | 4 | 1 |
| Physician Satisfaction with Procedure: Dissatisfied | 1 | 2 |
| Physician Satisfaction with Procedure: Extremely Dissatisfied | 0 | 0 |
Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).
| Participants | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping |
|---|---|---|
| Physician Satisfaction with Procedure: Extremely Satisfied | 10 | 4 |
| Physician Satisfaction with Procedure: Satisfied | 38 | 27 |
| Physician Satisfaction with Procedure: Neutral | 0 | 9 |
| Physician Satisfaction with Procedure: Dissatisfied | 0 | 3 |
| Physician Satisfaction with Procedure: Extremely Dissatisfied | 0 | 0 |
Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).
| Participants | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Physician Satisfaction with Procedure: Extremely Satisfied | 62 |
| Physician Satisfaction with Procedure: Satisfied | 57 |
| Physician Satisfaction with Procedure: Neutral | 4 |
| Physician Satisfaction with Procedure: Dissatisfied | 2 |
| Physician Satisfaction with Procedure: Extremely Dissatisfied | 0 |
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.
| score on a scale | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days. | 28.1 ± 6.18 |
Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.
| score on a scale | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Patient Satisfaction as Measured by a Validated Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days. | 30.9 ± 4.87 |
Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
| % of vein length | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Target Vein at the Time of Index Procedure as Measured by the Percentage of Target Veins Successfully Treated. | 90.8 ± 13.21 |
| reintervention per vein-years | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months, Assessed at Each Follow-up Visit. | 0.028 |
Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 60 months
| services utilized per person-years | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| Inpatient Visits | 0.0000 | 0.0023 |
| Hospital Outpatient Visits | 0.0813 | 0.0593 |
| Clinic Visits | 0.1802 | 0.1802 |
| Outpatient ER Visits | 0.0088 | 0.0023 |
Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 60 months.
| services utilized per person-years | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Inpatient Visits | 0.0776 |
| Hospital Outpatient Visits | 0.4912 |
| Clinic Visits | 5.9044 |
| Outpatient ER Visits | 0.1228 |
| Participants | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| Diagnostic Test Performed: Computed Tomographic Venography | 0 | 0 |
| Diagnostic Test Performed: DUS | 24 | 12 |
| Diagnostic Test Performed: Magnetic Resonance Venography | 0 | 0 |
| Diagnostic Test Performed: Venogram | 0 | 0 |
| Diagnostic Test Performed: Intravascular Ultrasound | 0 | 0 |
| Diagnostic Test Performed: Other | 1 | 1 |
| Actions Taken: Medication Change | 16 | 7 |
| Actions Taken: Intervention Involving Target Limb/Vein | 6 | 0 |
| Hospitalization | 0 | 1 |
| Prolongation of Existing Hospitalization | 0 | 0 |
| Other Actions | 3 | 2 |
| Participants | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Diagnostic Tests Performed: Computed Tomographic Venography | 1 |
| Diagnostic Tests Performed: DUS | 18 |
| Diagnostic Tests Performed: Magnetic Resonance Venography | 1 |
| Diagnostic Tests Performed: Venogram | 0 |
| Diagnostic Tests Performed: Intravascular Ultrasound | 0 |
| Diagnostic Test Performed: Other | 10 |
| Actions Taken: Medication Change | 18 |
| Actions Taken: Intervention Involving Target Limb/Vein | 5 |
| Hospitalization | 6 |
| Prolongation of existing hospitalization | 1 |
| Other Actions | 10 |
As measured by the time between the index procedure and the first reintervention procedure. Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 60 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 60 months.
| percentage probability | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| 12 months | 97.6 | 100 |
| 24 months | 96.7 | 100 |
| 36 months | 95.8 | 100 |
| 48 months | 95.8 | 98.6 |
| 60 months | 95.8 | — |
As measured by the time between the index procedure and the first reintervention procedure. Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 60 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 60 months.
| percentage probability | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| 12 months | 97.2 |
| 24 months | 92.8 |
| 36 months | 88.3 |
| 48 months | 88.3 |
Time to ulcer recurrence reported by using the cumulative incidence probability estimate of the event happening at 60 months, expressed as a percentage. Ulcer recurrence could only occur after the initial ulcer had completely healed.
| percentage probability | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| 12 Months | 15.4 |
| 24 Months | 22.9 |
| 36 Months | 29.7 |
| 48 Months | 29.7 |
As measured by the time between initial ulcer healing and the first ulcer recurrence.
| days | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Ulcer Free Time, Calculated as Days Between Initial Ulcer Healing and First Ulcer Recurrence, as Applicable, Through 60 Months. | 346.60 ± 314.31 |
Ulcer healing rate, as measured by the percentage of the ulcer area healed, according to an independent core laboratory through 24 months or until ulcer healing has been confirmed. This was assessed by overall number of wound care utilizations, and also by different wound care treatments subtypes.
| % of area healed | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Ulcer Healing Rate, as Measured by the Percentage of the Ulcer Area Healed, Through 24 Months. | 98.46 ± 10.92 |
Determined by the number of ulcer wound care treatments utilized between study visits through 60 months.
| treatments utilizations per person-years | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Overall Wound Cares | 1.49 |
| Debridements | 0.55 |
| Skin Grafts | 0.03 |
| Dressing Changes | 1.38 |
| Unna Boots | 0.25 |
| Others | 0.08 |
Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).
| Participants | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA |
|---|---|---|
| Symptomatic pulmonary embolism (PE) | 2 | 0 |
| Serious Adverse Event (SAE) | 12 | 11 |
Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).
| Participants | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|
| Symptomatic pulmonary embolism (PE) | 2 |
| Serious Adverse Event (SAE) | 55 |
Collected over from index procedure until end of follow-up, up to 60 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | 0/136 (0%) | 12/136 (8.8%) | 23/136 (16.9%) |
| Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | 1/139 (0.7%) | 11/139 (7.9%) | 8/139 (5.8%) |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | 0/53 (0%) | 1/53 (1.9%) | 9/53 (17%) |
| Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping | 0/53 (0%) | 4/53 (7.5%) | 4/53 (7.5%) |
| Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System | 18/125 (14.4%) | 55/125 (44%) | 50/125 (40%) |
| Event | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|---|---|---|---|
| CellulitisInfections and infestations | 1/136 | 0/139 | 0/53 | 0/53 | 8/125 |
| Septic ShockInfections and infestations | 0/136 | 0/139 | 0/53 | 0/53 | 8/125 |
| Cardiac Failure CongestiveCardiac disorders | 0/136 | 0/139 | 0/53 | 0/53 | 6/125 |
| DeathGeneral disorders | 0/136 | 0/139 | 0/53 | 0/53 | 6/125 |
| HyponatraemiaMetabolism and nutrition disorders | 0/136 | 0/139 | 0/53 | 0/53 | 3/125 |
| Acute Kidney InjuryRenal and urinary disorders | 0/136 | 0/139 | 0/53 | 0/53 | 3/125 |
| Acute Respiratory FailureRespiratory, thoracic and mediastinal disorders | 0/136 | 0/139 | 0/53 | 0/53 | 3/125 |
| Skin UlcerSkin and subcutaneous tissue disorders | 0/136 | 0/139 | 0/53 | 0/53 | 3/125 |
| Superficial Vein ThrombosisVascular disorders | 0/136 | 0/139 | 0/53 | 0/53 | 3/125 |
| Human BiteInjury, poisoning and procedural complications | 0/136 | 0/139 | 0/53 | 1/53 | 0/125 |
| Event | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System |
|---|---|---|---|---|---|
| Skin UlcerSkin and subcutaneous tissue disorders | 0/136 | 0/139 | 0/53 | 0/53 | 35/125 |
| Venous RecanalisationVascular disorders | 6/136 | 4/139 | 2/53 | 0/53 | 17/125 |
| HypersensitivityImmune system disorders | 8/136 | 1/139 | 5/53 | 0/53 | 0/125 |
| Peripheral Venous DiseaseVascular disorders | 2/136 | 3/139 | 1/53 | 4/53 | 5/125 |
| Infected Skin UlcerInfections and infestations | 0/136 | 0/139 | 0/53 | 0/53 | 8/125 |
| PhlebitisVascular disorders | 8/136 | 0/139 | 1/53 | 0/53 | 4/125 |
| CellulitisInfections and infestations | 0/136 | 1/139 | 0/53 | 0/53 | 7/125 |
| Age, Continuous(years) | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System | Total |
|---|---|---|---|---|---|---|
| Mean | 57.0 ± 13.20 | 57.2 ± 13.70 | 60.3 ± 14.39 | 61.5 ± 12.96 | 67.9 ± 14.76 | 60.7 ± 14.52 |
| Sex/Gender, Customized(Participants) | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System | Total |
|---|---|---|---|---|---|---|
| Female | 91 | 78 | 29 | 33 | 48 | 279 |
| Male | 40 | 52 | 21 | 16 | 77 | 206 |
| Race/Ethnicity, Customized(Participants) | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System | Total |
|---|---|---|---|---|---|---|
| Not reportable per local laws or regulations | 67 | 69 | 7 | 4 | 55 | 202 |
| Subject declines to answer | 0 | 3 | 0 | 0 | 0 | 3 |
| Unknown | 0 | 0 | 0 | 0 | 3 | 3 |
| Black or African American | 1 | 1 | 0 | 0 | 3 | 5 |
| Chinese | 0 | 0 | 0 | 0 | 0 | 0 |
| Japanese | 0 | 0 | 0 | 0 | 0 | 0 |
| Korean | 13 | 14 | 38 | 41 | 0 | 106 |
| Native American or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific islander | 0 | 1 | 0 | 0 | 0 | 1 |
| White | 50 | 42 | 5 | 3 | 63 | 163 |
| Other Asian | 0 | 1 | 0 | 0 | 1 | 2 |
| Other | 0 | 0 | 0 | 0 | 0 | 0 |
| Body Mass Index(kg/m2) | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System | Total |
|---|---|---|---|---|---|---|
| Mean | 26.4 ± 4.92 | 27.9 ± 5.77 | 25.8 ± 5.77 | 24.2 ± 3.41 | 32.4 ± 9.35 | 28.1 ± 7.08 |
| CEAP: Clinical, Etiological, Anatomical, and Pathophysiological Classification(Participants) | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): VenaSeal™ System | Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): ETA | Randomized Study VenaSeal™ System Versus Surgical Stripping: VenaSeal™ System | Randomized Study VenaSeal™ System Versus Surgical Stripping: Surgical Stripping | Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System | Total |
|---|---|---|---|---|---|---|
| C0 | 0 | 0 | 0 | 0 | 0 | 0 |
| C1 | 0 | 0 | 0 | 0 | 0 | 0 |
| C2 | 43 | 48 | 22 | 23 | 0 | 136 |
| C3 | 61 | 53 | 17 | 18 | 0 | 149 |
| C4a | 28 | 25 | 12 | 9 | 0 | 74 |
| C4b | 4 | 4 | 1 | 2 | 0 | 11 |
| C5 | 0 | 9 | 1 | 1 | 0 | 11 |
| C6 | 0 | 0 | 0 | 0 | 125 | 125 |
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