Cyanoacrylate Closure Versus Surgical Stripping for Incompetent Saphenous Veins (CASS)

Kyung Hee University

Status: Unknown

Conditions: Occlusions Vein; Chronic Venous Insufficiency

Treatments: Procedure: Cyanoacrylate closure; Procedure: Surgical stripping

Study type: Interventional

Funder types: Other

Identifiers

NCT03835559

2018-03-030-001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 146 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Cyanoacrylate closure

Active Comparator group

Description:

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.

Treatment:

Procedure: Surgical stripping

Procedure: Cyanoacrylate closure

Surgical stripping

Active Comparator group

Description:

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.

Treatment:

Procedure: Surgical stripping

Procedure: Cyanoacrylate closure