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

Last updated: September 15, 2021
Sponsor: InnoVein
Overall Status: Active - Recruiting

Phase

N/A

Condition

Varicose Veins

Venous Thrombosis

Claudication

Treatment

N/A

Clinical Study ID

NCT04253301
IM-CP-2001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Willing and able to provide written Informed Consent
  • Diagnosis of symptomatic non-obstructive chronic valvular insufficiency of the femoralvein
  • Willing and medically able to receive intraprocedural and post-proceduralanticoagulation medication
  • Life expectancy >1yr
  • Reflux time >1s in the superficial femoral and/or popliteal vein

Exclusion

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 theIndex Procedure
  • Investigator or sponsor believes the subject would not benefit, would not beappropriate, be unable to follow-up, or be at high risk for non-compliance with theprotocol

Study Design

Total Participants: 5
Study Start date:
January 15, 2020
Estimated Completion Date:
January 15, 2027

Study 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.

Connect with a study center

  • Hollywood Private Hospital

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Flinders

    Adelaide,
    Australia

    Active - Recruiting

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