An interventional study of VenaSeal SCS and ClosureFast Radiofrequency Ablation (RFA) in Great Saphenous Vein (GSV) With Venous Reflux Disease, sponsored by Medtronic Endovascular. Completed at 10 sites in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-06-26.
Sponsored by Medtronic Endovascular · Not applicable, Interventional, and Treatment
The VeClose pivotal study was a controlled, randomized, prospective, multicenter, pivotal study in which patients with venous reflux in the great saphenous vein (GSV) were treated with either the VenaSeal closure system (VenaSeal SCS) or radiofrequency ablation (RFA) therapy.
The purpose of the VeClose study was to demonstrate safety and effectiveness of the VenaSeal SCS as being both 1) non-inferior to RFA therapy in achieving anatomical closure of lower extremity superficial truncal veins in patients with venous reflux through endovascular transcatheter embolization with coaptation of the GSV at 3 months, and 2) superior in the reduction of intraprocedural and post procedural pain and symptoms as compared to treatment with RFA.
The study was designed to demonstrate safety of the VenaSeal SCS by follow-up visits that evaluated, via duplex ultrasound and physical exam, the presence of deep vein thrombosis and/or pulmonary embolus.
1,066 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 242 is above the median of 72 across 711 interventional studies indexed under Gastroesophageal Reflux.
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Exclusion Criteria:
Endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). The VA is dispensed in small amounts with each pull of the trigger equaling 0.10 cc. Subjects were randomized in a 1:1 ratio to either VenaSeal SCS or to RFA.
Device: VenaSeal SCS
Endovenous insertion of the ClosureFast radiofrequency ablation (RFA) catheter into a target site in diseased great saphenous veins (GSV). Heat is applied to the target vein using radiofrequency energy to ablate the target vein. Subjects were randomized in a 1:1 ratio to either VenaSeal SCS or RFA.
Device: ClosureFast Radiofrequency Ablation (RFA)
Prior to initiation of the randomized cohort at each site, a non-randomized cohort of 2 subjects per clinical site (roll-in phase) were enrolled and treated with VenalSeal SCS with endovenous delivery of VenaSeal Adhesive (VA) to a target site in diseased great saphenous veins (GSV). The VA is dispensed in small amounts with each pull of the trigger equaling 0.10 cc.
Device: Roll-in (VenaSeal SCS)
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
Also known as: VenaSeal Sapheon Closure System, VSCS
Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.
Also known as: ClosureFast
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
Also known as: VenaSeal Sapheon Closure System, VSCS, Roll-in
Number of Participants With Complete Closure of the Target Vein at 3 Months
The primary endpoint of the study was complete closure of the target vein at 3 months after index treatment as judged by the vascular ultrasound laboratory. Complete closure was defined as Doppler ultrasound examination showing closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.
Time frame: 3 months
Intraoperative Pain
After the procedure, pain experienced during the procedure was rated by the subjects on a 0-10 numeric rating scale (NRS) where 0 represents no pain whatsoever and 10 represents worst imaginable pain.
Time frame: During the operative procedure, which was an average of 24 minutes for VenaSeal SCS, 19 minutes for RFA, and 31 minutes for Roll-in group.
Ecchymosis at Day 3
At the Day 3 visit, the investigator visually rated the subject's ipsilateral leg for the occurrence of ecchymosis along the treated area based on a Scale for Ecchymosis Assessment with a 0-5 rating scale, with 0 being the best possible outcome and 5 being the worst possible outcome. The treatment area was defined as the area of skin overlying the treated vein, excluding the 5 cm of skin immediately adjacent to the access site. The rating scale was based on the percentage of ecchymosis of the treated area according to the following criteria: 0 rating = no ecchymosis, 1. rating = less than 25% ecchymosis, 2. rating = 25-50% ecchymosis, 3. rating = 50-75% ecchymosis, 4. rating = 75-100% ecchymosis, 5. rating = extension of ecchymosis above or below the treated area.
Time frame: First follow up visit at day 3
The VeClose pivotal study was a prospective, multicenter, randomized, controlled study in which patients with venous reflux in the great saphenous vein (GSV) were treated with either VenaSeal SCS or radiofrequency ablation (RFA) therapy. Patients were treated between March 2013 and September 2013. There were 10 sites with 242 subjects.
| Milestone | Roll-In (VenaSeal SCS) | VenaSeal SCS (Randomized Phase) | RFA (Randomized Phase) |
|---|---|---|---|
| Started | 20 | 108 | 114 |
| 3 mos | 20 | 108 | 113 |
| Completed | 19 | 104 | 108 |
| Not completed | 1 | 4 | 6 |
The primary endpoint of the study was complete closure of the target vein at 3 months after index treatment as judged by the vascular ultrasound laboratory. Complete closure was defined as Doppler ultrasound examination showing closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.
| Participants | VenaSeal SCS (Randomized Phase) | RFA (Randomized Phase) |
|---|---|---|
| Number of Participants With Complete Closure of the Target Vein at 3 Months | 107 | 109 |
After the procedure, pain experienced during the procedure was rated by the subjects on a 0-10 numeric rating scale (NRS) where 0 represents no pain whatsoever and 10 represents worst imaginable pain.
| scores on a scale | Roll-In (VenaSeal SCS) | VenaSeal SCS (Randomized Phase) | RFA (Randomized Phase) |
|---|---|---|---|
| Intraoperative Pain | 1.28 ± 1.53 | 2.16 ± 2.23 | 2.35 ± 2.18 |
At the Day 3 visit, the investigator visually rated the subject's ipsilateral leg for the occurrence of ecchymosis along the treated area based on a Scale for Ecchymosis Assessment with a 0-5 rating scale, with 0 being the best possible outcome and 5 being the worst possible outcome. The treatment area was defined as the area of skin overlying the treated vein, excluding the 5 cm of skin immediately adjacent to the access site. The rating scale was based on the percentage of ecchymosis of the treated area according to the following criteria: 0 rating = no ecchymosis, 1. rating = less than 25% ecchymosis, 2. rating = 25-50% ecchymosis, 3. rating = 50-75% ecchymosis, 4. rating = 75-100% ecchymosis, 5. rating = extension of ecchymosis above or below the treated area.
| Participants | Roll-In (VenaSeal SCS) | VenaSeal SCS (Randomized Phase) | RFA (Randomized Phase) |
|---|---|---|---|
| None | 15 | 73 | 55 |
| <25% | 5 | 29 | 38 |
| 25-50% | 0 | 3 | 16 |
| 50-75% | 0 | 2 | 4 |
| 75-100% | 0 | 1 | 1 |
Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Roll-In (VenaSeal SCS) | 0/20 (0%) | 1/20 (5%) | 7/20 (35%) |
| VenaSeal SCS (Randomized Phase) | 1/108 (0.9%) | 5/108 (4.6%) | 26/108 (24.1%) |
| RFA (Randomized Phase) | 0/114 (0%) | 6/114 (5.3%) | 15/114 (13.2%) |
| Event | Roll-In (VenaSeal SCS) | VenaSeal SCS (Randomized Phase) | RFA (Randomized Phase) |
|---|---|---|---|
| Ischemic ColitisGastrointestinal disorders | 1/20 | 0/108 | 0/114 |
| Symptomatic orthostatic hypotensionVascular disorders | 0/20 | 1/108 | 0/114 |
| Thyroid CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/20 | 1/108 | 0/114 |
| Small Bowel ObstructionGastrointestinal disorders | 0/20 | 1/108 | 0/114 |
| Cervical painMusculoskeletal and connective tissue disorders | 0/20 | 1/108 | 0/114 |
| Liver cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/20 | 1/108 | 0/114 |
| Right breast invasive lobular carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/20 | 1/108 | 0/114 |
| Suicide attemptPsychiatric disorders | 0/20 | 1/108 | 0/114 |
| Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/20 | 0/108 | 1/114 |
| CellulitisInfections and infestations | 0/20 | 0/108 | 1/114 |
| Event | Roll-In (VenaSeal SCS) | VenaSeal SCS (Randomized Phase) | RFA (Randomized Phase) |
|---|---|---|---|
| Superficial vein thrombophlebitisVascular disorders | 3/20 | 0/108 | 0/114 |
| Phlebitis in treatment zoneVascular disorders | 2/20 | 12/108 | 9/114 |
| OtherMusculoskeletal and connective tissue disorders | 2/20 | 8/108 | 0/114 |
| Phlebitis not in treatment zoneVascular disorders | 0/20 | 8/108 | 6/114 |
| Age, Continuous(years) | Roll-In (VenaSeal SCS) | VenaSeal SCS (Randomized Phase) | RFA (Randomized Phase) | Total |
|---|---|---|---|---|
| Mean | 53.1 (36 to 65) | 49.0 (26 to 70) | 50.5 (25 to 70) | 50.1 (25 to 70) |
| Sex: Female, Male(Participants) | Roll-In (VenaSeal SCS) | VenaSeal SCS (Randomized Phase) | RFA (Randomized Phase) | Total |
|---|---|---|---|---|
| Female | 17 | 83 | 93 | 193 |
| Male | 3 | 25 | 21 | 49 |
Plan to share: No
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