Lake Washington Vascular VenaSeal™ Post-Market Evaluation (WAVES)

Study Overview
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Brief Summary
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The VenaSeal Closure system offers an outpatient treatment option for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. VenaSeal is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).

Official Title
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Lake Washington Vascular VenaSeal™ Post-Market Evaluation: WAVES

Conditions
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Venous Reflux

Intervention / Treatment
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* Device: SP-402 VenaSeal™ Closure System


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Reflux in at least one target vein; One or more of the following symptoms related to a TV: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling; CEAP classification of C2 (if symptomatic) through C5; Key Exclusion Criteria: Current, regular use of systemic anticoagulation; Previous or suspected deep vein thrombosis or pulmonary embolus, or active acute superficial thrombophlebitis, or thrombophlebitis migrans; Previous treatment such as laser or radiofrequency ablation of venous disease in targeted vein segment; Known hypercoagulable disorder; Pregnant or breast feeding at enrollment; Known sensitivity to cyanoacrylate adhesives; Venous treatment in the contralateral limb within the last 30 days, or who require contralateral treatment within three months; Planned to undergo additional ipsilateral treatments on the same leg within 3 months following treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Historical Control with Propensity Analysis<br> | Device: SP-402 VenaSeal™ Closure System<br>* A medical device kit consisting of seven delivery tools and the proprietary VenaSeal™ Adhesive (Medtronic Cardiovascular, Santa Rosa, CA). The device is used to treat venous reflux in lower extremity superficial truncal veins for subjects in the treatment arm..<br>* Other names: VenaSeal™;|
| Experimental: VenaSeal Treatment Arm<br> | Device: SP-402 VenaSeal™ Closure System<br>* A medical device kit consisting of seven delivery tools and the proprietary VenaSeal™ Adhesive (Medtronic Cardiovascular, Santa Rosa, CA). The device is used to treat venous reflux in lower extremity superficial truncal veins for subjects in the treatment arm..<br>* Other names: VenaSeal™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete closure (CC) of the PTVS as assessed by duplex ultrasound 1 month after the index procedure. | CC of the PTVS as assessed by duplex ultrasound 1 month after the index procedure. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CC of the PTVS, as assessed by duplex ultrasound |  | 1 week and 3 months after treatment | 
| CC of Treated Vein Segments (TVS), expressed on a per-segment basis, as assessed by duplex ultrasound |  | 1 month and 3 months after the index procedure | 
| Quality of life as measured by the venous clinical severity scores (rVCSS) |  | 1 and 3 months after treatment | 
| Quality of life as measured by the Aberdeen Varicose Vein Questionnaire (AVVQ) |  | 1 and 3 months after treatment | 
| Quality of life as measured by the EQ-5D |  | 1 and 3 months after treatment | 
| Return to normal activities and return to work; day of procedure is day 0 |  | 1 week, 1 month | 
| Need for adjunctive treatment | Measured in case report form (yes or no, and if yes, the Investigator will specify what the adjunctive measure is). | 3 months | 
| Safety and adverse event for below the knee greater saphenous vein treatment |  | 1 week, 1 month, 3 months | 
| Safety and adverse events for large diameter TVS defined as veins larger than 8 mm in diameter |  | 1 week, 1 month, 3 months | 
| Patient satisfaction | At selected visits, the subject will complete a brief questionnaire rating satisfaction with treatment provided and whether the subject would undergo the treatment again. | 1 week, 1 month, 3 months | 
| CC of TVS, expressed on a per-segment basis |  | 1 month and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Varicose Veins, Great Saphenous Vein, Venous Insufficiency