VenaSeal Sapheon Closure System Pivotal Study (VeClose)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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VenaSeal Sapheon Closure System vs. Radiofrequency Ablation for Incompetent Greater Saphenous Veins

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: Age ≥ 21 years and ≤ 70 years of age at the time of screening Reflux in the great saphenous vein (GSV) greater than 0.5 sec reflux One or more of the following symptoms related to the target vein: aching, throbbing, heaviness, fatigue, pruritis, night cramps, restlessness, generalized pain or discomfort, swelling GSV diameter while standing of 3-12 mm throughout the target vein as measured by Duplex ultrasound Clinical, etiology, assessment and pathophysiology (CEAP) classification of C2 (if symptomatic) - C4b Ability to walk unassisted Ability to attend follow-up visits Ability to understand the requirements of the study and to provide informed consent Exclusion Criteria: Life expectancy < 1 year Active treatment for malignancy other than non-melanoma skin cancer Symptomatic peripheral arterial disease with ankle-brachial index (ABI) <0.89 Daily use of narcotic or non-steroidal anti-inflammatory pain medications to control pain associated with GSV reflux Current, regular use of systemic anticoagulation (e.g., warfarin, heparin) Previous or suspected deep vein thrombosis (DVT) or pulmonary embolus (PE) Previous superficial thrombophlebitis in GSV Previous treatment of venous disease in target limb, other than spider vein treatment Known hypercoagulable disorder Conditions which prevent vein treatment with either RFA or VenaSeal SCS Immobilization or inability to ambulate Pregnant prior to enrollment Tortuous GSV, which, in the opinion of the investigator, will limit catheter placement or require more than one primary access site Aneurysm of the target vein with local diameter >12 mm Significant, incompetent, ipsilateral small saphenous, intersaphenous or anterior accessory great saphenous vein(s) Known sensitivity to cyanoacrylate (CA) adhesives Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment Patients who require bilateral treatment during the next 3 months Patients who require additional ipsilateral treatments on the same leg within 3 months following treatment

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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Design Details

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


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. | 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 (ClosureFast)<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 RFA. | 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, 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)<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 |
| --- | --- | --- |
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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, rating = less than 25% ecchymosis, rating = 25-50% ecchymosis, rating = 50-75% ecchymosis, rating = 75-100% ecchymosis, rating = extension of ecchymosis above or below the treated area. | First follow up visit at day 3 | 

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