A Feasibility Study of the ReLeaf Catheter System

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Feasibility Study of the InterVene ReLeaf Catheter System in the Creation of Tissue Leaflets in the Femoral and/or Popliteal Vein

Conditions
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Chronic Venous Insufficiency

Intervention / Treatment
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* Device: ReLeaf


Participation Criteria
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Eligibility Criteria
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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. Comorbidity risks which, in the opinion of the Investigator, limit longevity or likelihood of complying with protocol follow up. General contraindications to surgery or the use of anesthesia. Uncontrolled heart failure, or NYHA Class III or IV heart failure. Open Cardiac surgery (e.g. ventriculotomy, atriotomy) within the past 6 months of consent (Interventional procedures such as stenting or PTCA do not apply.) Chronic Kidney Disease with creatinine level of 2mg/dL or higher. Active systemic infection or sepsis. Pregnant or lactating (positive pregnancy test, women of childbearing potential must be tested). Appropriate vascular access is precluded. Subject is enrolled in any other clinical study that, in the opinion of the Investigator, may conflict with this study or compromise study results. Subject is considered at high risk for non-compliance with the protocol (e.g., inaccessible for follow-up). Other invasive surgical procedure within the last 90 days that in the Investigator's opinion would interfere with the study procedure or results. History of stroke within the last 6 months. Subject is incarcerated or will be incarcerated during the course of the study. Untreated significant superficial venous incompetence

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Subject to undergo the ReLeaf study procedure. | Device: ReLeaf<br>* The ReLeaf catheter is expected to enable a physician to create tissue leaflets that, in turn, generate a valve effect in the deep veins of the legs.<br>* Other names: Tissue Leaflet Creation, Creation of Valve-like Effect;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Feasibility | 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. | Day 0 | 
| Safety (The number of SAEs directly attributable to the study device will be used as a measure of safety) | 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. | Day 30 |