Cyanoacrylate Closure Versus Surgical Stripping for Incompetent Saphenous Veins (CASS)
Occlusions Vein, Chronic Venous Insufficiency
About this trial
This is an interventional treatment trial for Occlusions Vein focused on measuring varicose vein, stripping, endovenous, ablation, Occlusion, quality of life
Eligibility Criteria
Inclusion Criteria:
- 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
- Clinical, Etiologic, Anatomic, and Pathophysiologic classification of C2 through C5
Exclusion Criteria:
- 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 greater saphenous vein 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
Sites / Locations
- In-Mok JungRecruiting
- Jin Hyun JohRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Cyanoacrylate closure
Surgical stripping
After successful access of target vein and insertion of guidewire under any type of anesthesia, the procedure of cyanoacrylate closure for treatment of incompetent Saphenous Veins is performed. A 5 French introducer and catheter is advanced and positioned 5.0 cm caudal to the junction with proximal saphenous vein compression by the ultrasound probe, two injections of approximately 0.10 mL glue are given 1 cm apart, followed by a 3min period of compression, and then repeat injections and 30sec ultrasound probe and hand compression sequences until the entire length of the target vein is treated. The catheter is removed.
For treatment of incompetent Saphenous Veins, surgical stripping is performed with a proper incision in the groin, with division and ligation of the saphenous vein and division of all tributaries under all types of anesthesia (general, spinal, regional block, or local anesthesia). The saphenous vein is then removed using a stripper. Compression stocking is apply.