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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
242
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.
Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
Morrison Vein Institute
Scottsdale, Arizona, United States
GBK Cosmetic Laser Dermatology
San Diego, California, United States
Radiology Imaging Associates (RIA)
Greenwood Village, Colorado, United States
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.
Time frame: 3 months
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.
Time frame: 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, 1. rating = less than 25% ecchymosis, 2. rating = 25-50% ecchymosis, 3. rating = 50-75% ecchymosis, 4. rating = 75-100% ecchymosis, 5. rating = extension of ecchymosis above or below the treated area.
Time frame: First follow up visit at day 3
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Vein Clinics of America
Oakbrook Terrace, Illinois, United States
Prairie Education & Research Cooperative
Springfield, Illinois, United States
MD Laser Skin & Vein Institute
Hunt Valley, Maryland, United States
Vein Institute of Buffalo
North Tonawanda, New York, United States
Inovia Vein Specialty Center
Bend, Oregon, United States
Sentara Vascular Specialist
Virginia Beach, Virginia, United States
Lake Washington Vascular
Bellevue, Washington, United States