A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-22

Study Completion Date

2020-03-27

Brief Summary

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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 (STS) solution utilizing the ClariVein system.

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Detailed Description

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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 duration for individual study patients, including follow-up visits, is anticipated to be approximately 16 weeks.

Conditions

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Venous Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ClariVein RES 1% Injection

Sodium Tetradecyl Sulfate 1% Injection single administration

Group Type ACTIVE_COMPARATOR

ClariVein RES

Intervention Type DEVICE

ClariVein system

Sodium Tetradecyl Sulfate 1% Injection

Intervention Type DRUG

Sodium Tetradecyl Sulfate STS 1% Injection

ClariVein RES 3% Injection

Sodium Tetradecyl Sulfate 3% Injection single administration

Group Type ACTIVE_COMPARATOR

ClariVein RES

Intervention Type DEVICE

ClariVein system

Sodium Tetradecyl Sulfate 3% Injection

Intervention Type DRUG

Sodium Tetradecyl Sulfate 3% Injection

Interventions

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ClariVein RES

ClariVein system

Intervention Type DEVICE

Sodium Tetradecyl Sulfate 1% Injection

Sodium Tetradecyl Sulfate STS 1% Injection

Intervention Type DRUG

Sodium Tetradecyl Sulfate 3% Injection

Intervention Type DRUG

Other Intervention Names

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STS 1% STS 3%

Eligibility Criteria

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Inclusion Criteria

1. Adult patient with incompetent saphenous vein
2. Saphenous vein reflux \> 500ms (0.5s), as measured by duplex ultrasound
3. One or more of patient reported symptoms related to the target vein: i.e., heaviness, achiness, swelling, throbbing or itching.
4. Candidate for endovenous procedure

Exclusion Criteria

1. Arterial insufficiency demonstrated by a history of peripheral arterial disease (PAD) that would preclude the wearing of compression stockings
2. Absence of a palpable pulse at posterior tibial or dorsalis pedis and an Ankle-Brachial Index (ABI) \<0.6
3. Multi-segmental axial deep venous reflux in at least two contiguous venous segments (e.g., femoral and popliteal) in the ipsilateral extremity
4. Previous surgical or endovenous procedure in the treatment section of the target vein
5. Previous superficial thrombophlebitis of the target saphenous vein with scarring in the treatment section
6. Pregnant or breastfeeding
7. Known sensitivity or allergic response to Sodium Tetradecyl Sulfate (STS)
8. Known high risk of thrombosis
9. Known history of deep vein thrombus (DVT) or pulmonary embolism (PE), known history of acute superficial vein thrombus, known hypercoagulable condition, post thrombotic syndrome
10. Known history of anaphylaxis or presence of multiple severe allergies

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes