Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency

Study Overview
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Brief Summary
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This objective of this feasibility study is to evaluate the safety of the InnoVein Valve and Delivery System for treatment of chronic venous insufficiency.

Detailed Description
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Chronic Venous Insufficiency occurs when the venous wall and/or valves in the leg veins are not working effectively, making it difficult for blood to return to the heart from the legs.The core etiology of the disease stems from increased venous pressure and incompetent venous valves leading to regurgitation of blood that accumulates in the legs. It has been shown that implantation or recreation of a functional valve can lead to clearance of excess blood and resolution of symptoms. The InnoVein Valve and Delivery System is a new, investigational biocompatible valve intended to support natural flow in vessels in patients with Chronic Venous Insufficiency. The purpose of this study is to assess the safety of the InnoVein Valve and Delivery System for treatment of Chronic Venous Insufficiency.

Official Title
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Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency

Conditions
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Chronic Venous Insufficiency

Intervention / Treatment
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* Device: InnoVein Valve Treatment


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Willing and able to provide written Informed Consent Diagnosis of symptomatic non-obstructive chronic valvular insufficiency of the femoral vein Willing and medically able to receive intraprocedural and post-procedural anticoagulation medication Life expectancy >1yr Reflux time >1s in the superficial femoral and/or popliteal vein Key Exclusion Criteria: Any prior deep vein intervention within 6 months prior to the Index Procedure History of 2+ DVTs Inadequate inflow to the femoral vein or inadequate outflow through the femoral vein, iliac vein, or IVC Current IVC Placement History of pulmonary embolism within 6 months Conditions that increase the risk of device thrombosis or patient bleeding Any planned surgical or interventional procedure within 30 days prior to or after the Index Procedure Investigator or sponsor believes the subject would not benefit, would not be appropriate, be unable to follow-up, or be at high risk for non-compliance with the protocol

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>Subjects will have the InnoVein Valve implanted | Device: InnoVein Valve Treatment<br>* Subjects will have the InnoVein Valve implanted<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the InnoVein Valve and Delivery System: Number of Major Adverse Events | Number of Major Adverse Events | 30 Days |