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

  • STATUS
    Recruiting
  • End date
    Jan 15, 2026
  • participants needed
    5
  • sponsor
    InnoVein
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Updated on 19 February 2024
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venous insufficiency
reflux

Summary

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

Description

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.

Details
Condition Chronic Venous Insufficiency
Age 18years - 100years
Treatment InnoVein Valve Treatment
Clinical Study IdentifierNCT04253301
SponsorInnoVein
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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

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
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