Cyanoacrylate Closure Versus Surgical Stripping for Incompetent Saphenous Veins

Randomized Controlled Trial Comparing the Clinical Outcomes After Cyanoacrylate Closure and Surgical Stripping for Incompetent Saphenous Veins

The purpose of this study is to evaluate the non-inferior, clinical outcomes after cyanoacrylate closure comparing the surgical stripping for incompetent saphenous veins.

Varicose veins are highly prevalent. In western countries, an estimated 23% of adults have varicose veins, and 6% have more advanced chronic venous disease, including skin changes and healed or active venous ulcers. There are several modalities to treat varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein, combined with excision of large varicosities, has been the standard of care for many years. Endovenous thermal ablation by radiofrequency ablation (RFA) or endovenous laser ablation (EVLA) has been shown to be a safe and effective alternatives with high long-term target vein closure rates. Although both techniques have gained broad acceptance in many countries, one major disadvantage of these techniques is the requirement for use of tumescent anesthesia to avoid the thermal injury of the surrounding structures. Cyanoacrylate closure for varicose veins has recently been introduced for treatment of the incompetent saphenous vein.

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