Randomized controlled trial comparing the clinical outcomes after cyanoacrylate closure with VenaSeal™ Closure System and surgical stripping for incompetent saphenous veins

Kyung Hee University Hosipital at Gangdong0 个研究点目标入组 146 人开始时间: 待定最近更新: 2019年3月11日

试验速览

暂无简介。

•Age between 18 and 80 years of age at the time of enrollment
•- Reflux in great saphenous vein greater than 0.5 seconds after distal compression and release or Valsalva’s maneuver in the standing or reverse Trendelenburg position
•- Diameter of saphenous vein between 2mm to 20mm (with standing position)
•- One or more of the following symptoms related to the incompetent saphenous vein: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling
•- CEAP classification of C2 through C5

•- Previous treatment in targeted vein segment
•- Tortuous vein in which the delivery catheter cannot be inserted
•- Aneurysm of target vein segment >20 mm
•- Daily use of narcotic or nonsteroidal anti-inflammatory pain medications to control pain associated with GSV reflux
•- Known hypercoagulable disorder
•- Active malignancy
•- Regular use of systemic anticoagulation
•- Current use of systemic anticoagulant
•- Previous deep vein thrombosis/pulmonary embolism or active acute superficial
•thrombophlebitis
•- Unable to comply with the schedule and protocol evaluations
•- Unable to ambulate
•- Currently pregnant or breast feeding
•- Known sensitivity to cyanoacrylate adhesives
•- Symptomatic peripheral arterial disease with ankle-brachial index <0.9
•- Participation in another clinical study that has not reached primary endpoint within 30 days prior to enrollment
•- Any condition which in the opinion of the investigator could compromise subject safety or adherence to the protocol

发起方

Kyung Hee University Hosipital at Gangdong