VeClose Five Year Follow-Up Extension Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Follow-up of Patients Treated in VeClose Study (Five Years)

Conditions
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Great Saphenous Vein (GSV) With Venous Reflux Disease

Intervention / Treatment
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* Device: VenaSeal SCS
* Device: ClosureFast Radiofrequency Ablation (RFA)
* Device: Roll-In (VenaSeal SCS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in the VeClose study. Able and willing to complete the required 5 year study visit including Duplex ultrasound exam. Able and willing to provide written informed consent prior to study specific data collection. Exclusion Criteria: 1. Withdrew consent from the VeClose study.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VenaSeal SCS<br>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<br>* Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.<br>* Other names: VSCS;|
| Active Comparator: RFA<br>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)<br>* Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.<br>* Other names: ClosureFast;|
| Experimental: Roll-in (VenaSeal SCS)<br>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)<br>* Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.<br>* Other names: Roll-in;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | 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. | 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). | 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. | 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) | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GSV