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

Not Applicable

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0003203
• Lead Sponsor: Kyung Hee University Hosipital at Gangdong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 146

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
- CEAP 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 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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Closure rate of the target vein

Secondary Outcome Measures

Name	Time	Method
Perioperative pain;Ecchymosis;Venous Clinical Severity Score;Quality of life score;Satisfaction of the patients;Serious Adverse Events