VenaSeal Sapheon Closure System vs. Radiofrequency Ablation for Incompetent Greater Saphenous Veins
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Great Saphenous Vein (GSV) With Venous Reflux Disease
- Sponsor
- Medtronic Endovascular
- Enrollment
- 242
- Locations
- 10
- Primary Endpoint
- Number of Participants With Complete Closure of the Target Vein at 3 Months
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Participants With Complete Closure of the Target Vein at 3 Months
Time Frame: 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.
Secondary Outcomes
- Intraoperative 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(First follow up visit at day 3)