EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence

Venclose, Inc.25 enrolled

Overview

This is a prospective, non-randomized study in which patients who meet eligibility criteria and consent to participate will undergo a minimally invasive procedure using radiofrequency (RF) energy for ablation of the great saphenous vein (GSV).

Subjects who meet eligibility criteria will undergo a procedure using the Venclose Radiofrequency (RF) System to treat the great saphenous vein. The technique involves percutaneous access and insertion of the endovenous sectional radiofrequency (EVSRF™) catheter into the target vein under ultrasound guidance and relies on the use of local anesthesia and thermal energy, from a radiofrequency generator, applied to the target vein. After each treatment, the EVSRF™ catheter is withdrawn a single length of the heating coil and another treatment is performed, until the entire vessel has been treated. After the treatment procedure, subjects will be evaluated four (4) times to assess vein recanalization and reflux, and to determine the incidence of adverse events.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Venous Insufficiency

Interventions

Venclose RF SystemDEVICE

Treatment of great saphenous vein (GSV) using Venclose RF System

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is male or female and 18 to 80 years old (inclusive) at time of enrollment (signing of consent). * Subject has significant venous reflux by Duplex Ultrasound (DUS), defined as reverse flow with reflux duration greater than 0.5 seconds after the Valsalva maneuver or distal augmentation while the patient is standing or in reverse Trendelenburg position. * Subject is eligible for endovascular treatment, as determined by the treating investigator. * Subject's general physical condition allows for a significant amount of ambulation after the procedure, as determined by the treating investigator. * Subject is willing and able to complete study requirements, including all follow-up visits and assessments. * Subject voluntarily provides written informed consent to participate in this study. Exclusion Criteria: * There is evidence of old or fresh thrombus in the subject's diseased vein segment to be treated, as determined by Duplex Ultrasound (DUS) within 2 weeks prior to the index procedure. * In the judgment of the treating investigator heat energy delivery to the subject would be contraindicated. * Subject is concurrently participating in another interventional clinical trial. * Subject is pregnant or plans to be pregnant or lactating at the time of the treatment procedure. * Subject has known or suspected allergies or contraindications to any general or local anesthetic agents and/or any antibiotic medication that cannot be adequately pre-treated.

Locations (1)

Venenzentrum am Bruehl

Leipzig, Germany

Outcomes

Primary Outcomes

Vein Occlusion Rate

Percentage of limbs with occlusion of the treated vein

Time frame: 3 days

Vein Occlusion Rate

Percentage of limbs with occlusion of the treated vein

Time frame: 3 months

Vein Occlusion Rate

Percentage of limbs with occlusion of the treated vein

Time frame: 6 months

Vein Occlusion Rate

Percentage of limbs with occlusion of the treated vein

Time frame: 12 months

Reflux-free Rate

Percentage of limbs without reflux in the treated vein

Time frame: 3 days

Reflux-free Rate

Percentage of limbs without reflux in the treated vein

Time frame: 3 months

Reflux-free Rate

Percentage of limbs without reflux in the treated vein

Time frame: 6 months

Reflux-free Rate

Percentage of limbs without reflux in the treated vein

Time frame: 12 months

Secondary Outcomes

Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification

Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer)

Data from ClinicalTrials.gov

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