An observational study in Great Saphenous Vein (GSV) With Venous Reflux Disease, sponsored by Medtronic Endovascular. Completed at 9 sites in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-04-12.
Sponsored by Medtronic Endovascular · Observational
The VeClose Five Year Follow-up Extension Study will seek to gain additional follow-up data from the patients enrolled in the VeClose study (NCT01807585).
The VeClose Five Year Follow-up Extension Study will continue to assess the safety and efficacy of the VenaSeal Closure System for the long term effect on closure of the great saphenous vein by conducting a follow-up visit at five years post index procedure/enrollment in the VeClose study.
Subjects currently enrolled in both arms of the VeClose Study (NCT01807585) will be assessed for eligibility to enroll in the VeClose Five Year Follow-up Extension Study. All subjects must meet the inclusion criteria and must not meet the exclusion criteria. Assessment of eligibility is based on data available to the investigator at the time of subject enrollment. The subject will be considered to be enrolled in the VeClose Five Year Follow-up Extension Study after the informed consent is signed/dated and all of the study eligibility criteria have been met.
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 at the time of enrollment into the VeClose study (NCT01807585).
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 to RFA at the time of enrollment into the VeClose study (NCT01807585).
Device: ClosureFast Radiofrequency Ablation (RFA)
Prior to initiation of the randomized cohort at each site for the VeClose study (NCT01807585), a non-randomized cohort of 2 subjects per site (roll-in phase) were enrolled and treated with VenaSeal 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
Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585).
Complete closure is defined as Doppler ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5cm.
Time frame: 5 years
Venous Clinical Severity Score (VCSS)
Change in Venous Clinical Severity Score (VCSS) at 5 years as compared to baseline data from the VeClose study (NCT01807585). The VCSS is an Investigator assessment of the severity of venous reflux disease, assessing signs and symptoms such as pain, varicose veins, venous edema, skin pigmentation, induration and inflammation. The VCSS score is the sum of responses to 10 questions. Each question has a total possible of 3 points, which are then added for each question. The overall VCSS scores can therefore range from 0 (no venous disease) to 30 (severe venous disease). High scores indicate worse outcomes and "0" is the best possible outcome.
Time frame: 5 years
Aberdeen Varicose Vein Questionnaire (AVVQ)
Change in Aberdeen Varicose Vein Questionnaire (AVVQ) at 5 years as compared to baseline data from the VeClose study (NCT01807585). AVVQ is a disease-specific 13-item questionnaire used to assess the impact of varicose veins on the quality of life, such as pain caused by varicose veins, and need to take painkilling tablets for varicose veins as well as assessing the presence of signs/symptoms such as ankle swelling, purple discoloration and rash/eczema. The total score of AVVQ is the sum of all questions for each leg. Scores range from 0 (no disease) to 100 (maximal disease). High scores indicate worse outcomes and "0" is the best possible outcome.
Time frame: 5 years
Quality of Life survey (EQ-5D)
Change in Quality of Life survey (EQ-5D) at 5 years as compared to baseline data from the VeClose study (NCT01807585). EQ-5D is a short generic quality of life survey that is commonly used outside of the United States for health technology assessments. The "health state today" question provides an overall assessment along a 20-cm visual analog scale (VAS) with a range from 0 ("worst imaginable health state") to 100 ("best imaginable health state").
Time frame: 5 years
CEAP classification ("clinical, etiology, assessment and pathophysiology")
Standardized measure of the degree of venous insufficiency and secondary manifestations of venous disease as measured by the treating physician.
Time frame: 5 years
Satisfaction with Treatment
Satisfaction with Treatment assessment consists of a brief 2-question patient survey rating satisfaction with treatment provided and whether the subject would undergo the assigned treatment again. The number (percent) of subjects on each level of satisfaction are summarized (Very satisfied, Somewhat satisfied, Somewhat dissatisfied, Very dissatisfied). The number (percent) of subjects for the second satisfaction question, "would undergo treatment again" were also summarized by response (Definitely have again, Might have again, Not have again).
Time frame: 5 years
Adverse events (AE) related to the target GSV
AEs related to the GSV will be tabulated and reporting using the MedDRA dictionary, version 16.1.
Time frame: 5 years
Adjunctive procedures performed on the study limb
Details of adjunctive procedures performed on the study limb will be captured on Case Report Forms (CRFs)
Time frame: 5 years
Plan to share: No
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Medtronic Endovascular