Status:
UNKNOWN
Cyanoacrylate Closure Versus Surgical Stripping for Incompetent Saphenous Veins
Lead Sponsor:
Kyung Hee University Hospital at Gangdong
Conditions:
Occlusions Vein
Chronic Venous Insufficiency
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the non-inferior, clinical outcomes after cyanoacrylate closure comparing the surgical stripping for incompetent saphenous veins.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT03835559
Start Date
April 10 2019
End Date
February 1 2021
Last Update
April 16 2019
Active Locations (2)
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1
In-Mok Jung
Seoul, Non US/Canada, South Korea, 05278
2
Jin Hyun Joh
Seoul, Non US/Canada, South Korea, 05278