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

RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2020-01-15

    Primary completion: 2022-02-15

    Study completion finish: 2027-01-15

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT04253301

    Intervention or treatment

    DEVICE: InnoVein Valve Treatment

    Conditions

    • Chronic Venous Insufficiency

    Find a site

    Closest Location:

    Sir Charles Gairdner Hospital

    Research sites nearby

    Select from list below to view details:

    • Sir Charles Gairdner Hospital

      Nedlands, Western Australia, Australia

    • Hollywood Private Hospital

      Nedlands, Western Australia, Australia

    • Flinders

      Adelaide, Not Specified, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Treatment
    • Subjects will have the InnoVein Valve implanted
    DEVICE: InnoVein Valve Treatment
    • Subjects will have the InnoVein Valve implanted

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Safety of the InnoVein Valve and Delivery System: Number of Major Adverse EventsNumber of Major Adverse Events30 Days

    Secondary outcome

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency

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