A Feasibility Study of the InterVene ReLeaf Catheter System in the Creation of Tissue Leaflets in the Femoral and/or Popliteal Vein
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Venous Insufficiency
- Sponsor
- Intervene, Inc.
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Technical Feasibility
- Status
- Terminated
- Last Updated
- 9 months ago
Overview
Brief Summary
This study is designed to evaluate the safety and technical feasibility of the ReLeaf Catheter System in the creation of one or more tissue leaflets in the femoral and/or popliteal vein in subjects with chronic venous insufficiency and who meet the protocol entry criteria.
Detailed Description
The ReLeaf catheter system is intended for the creation of tissue leaflets in the deep veins where existing valve structures are no longer healthy and effectively moving blood. This study aims to treat subjects with a documented history of symptomatic chronic venous insufficiency in whom compression therapy for at least 6 months, combined with superficial venous and/or perforator surgery have failed to obtain clinical improvement. This clinical trial is designed to evaluate the safety and technical feasibility of the ReLeaf Catheter System in the creation of one or more tissue leaflets in the femoral and/or popliteal vein in subjects with chronic venous insufficiency and who meet the protocol entry criteria.
Investigators
Eligibility Criteria
Inclusion Criteria
- •History of symptomatic chronic venous insufficiency subjects, clinical category CEAP 3 or greater.
- •History of failed compression therapy (of at least 6 months), combined with superficial venous or perforator surgery.
- •Femoral and/or popliteal venous reflux of ≥ 1.0 seconds.
- •Deep system reflux with Kistner classification grade 2 or higher.
- •18 years of age or older at the time of consent.
- •Willing and able to sign the Ethics Committee (EC) approved informed consent form.
- •Willing to comply with follow-up evaluations and protocols.
Exclusion Criteria
- •In the Investigator's opinion, venous outflow obstruction that would inhibit adequate flow away from valve site.
- •Obstructive features in the femoral or popliteal vein below the proposed tissue leaflet creation site, which, in the Investigator's opinion, will not allow for sufficient blood flow to the tissue leaflet creation site.
- •Deep venous system intervention within 6 months of consent.
- •Obstructive features or irregularly small luminal diameter in the femoral vein which, in the opinion of the Investigator, will prohibit access to a tissue leaflet creation site.
- •Prior deep vein valve surgical intervention in the ipsilateral limb.
- •Ankle arthrodesis with secondary muscle atrophy or severely limited ambulation.
- •Limb-threatening circulatory compromise.
- •Contraindications to anticoagulation therapy that cannot be medically controlled.
- •History of symptomatic pulmonary embolism.
- •Acute venous thromboembolism within 3 months of consent.
Outcomes
Primary Outcomes
Technical Feasibility
Time Frame: Day 0
Technical feasibility will be evaluated as the ability of the ReLeaf Catheter System to access the target site and successfully modify tissue as confirmed by, and in the opinion of, the Investigator. Successful target site access and confirmed tissue modification will be used as a measure of technical feasibility.
Safety (The number of SAEs directly attributable to the study device will be used as a measure of safety)
Time Frame: Day 30
Safety will be evaluated as freedom from serious adverse events directly attributed to the investigational device. The number of SAEs directly attributable to the study device will be used as a measure of safety.