KCT0003203
Not yet recruiting
未知
Randomized controlled trial comparing the clinical outcomes after cyanoacrylate closure with VenaSeal™ Closure System and surgical stripping for incompetent saphenous veins
Kyung Hee University Hosipital at Gangdong0 sites146 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kyung Hee University Hosipital at Gangdong
- Enrollment
- 146
- Status
- Not yet recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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