Status:
TERMINATED
A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency
Lead Sponsor:
Vascular Insights, LLC
Conditions:
Venous Insufficiency
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
VICARES is a prospective randomized, controlled, multi-center, double blind study treating venous insufficiency associated with incompetent saphenous veins with 1% and 3% Sodium Tetradecyl Sulfate (ST...
Detailed Description
Approximately 50 subjects diagnosed with an incompetent saphenous vein will be randomized to either 1% STS or 3% STS solution delivered by the ClariVein system under ultrasound guidance. Study durati...
Eligibility Criteria
Inclusion
- Adult patient with incompetent saphenous vein
- Saphenous vein reflux \> 500ms (0.5s), as measured by duplex ultrasound
- One or more of patient reported symptoms related to the target vein: i.e., heaviness, achiness, swelling, throbbing or itching.
- Candidate for endovenous procedure
Exclusion
- Arterial insufficiency demonstrated by a history of peripheral arterial disease (PAD) that would preclude the wearing of compression stockings
- Absence of a palpable pulse at posterior tibial or dorsalis pedis and an Ankle-Brachial Index (ABI) \<0.6
- Multi-segmental axial deep venous reflux in at least two contiguous venous segments (e.g., femoral and popliteal) in the ipsilateral extremity
- Previous surgical or endovenous procedure in the treatment section of the target vein
- Previous superficial thrombophlebitis of the target saphenous vein with scarring in the treatment section
- Pregnant or breastfeeding
- Known sensitivity or allergic response to Sodium Tetradecyl Sulfate (STS)
- Known high risk of thrombosis
- Known history of deep vein thrombus (DVT) or pulmonary embolism (PE), known history of acute superficial vein thrombus, known hypercoagulable condition, post thrombotic syndrome
- Known history of anaphylaxis or presence of multiple severe allergies
Key Trial Info
Start Date :
September 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2020
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03311269
Start Date
September 22 2017
End Date
March 27 2020
Last Update
March 2 2022
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
The Vascular Experts
Darien, Connecticut, United States, 06820
2
Capitol Vein and Laser Centers
Frederick, Maryland, United States, 21702
3
Southeastern Surgical Associates
Hyannis, Massachusetts, United States, 02601
4
Englegwood Hospital and Medical Center
Englewood, New Jersey, United States, 07631