Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

RECRUITING

To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).

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Study details:

Prospective, non-randomized, multicenter pre-market feasibility study to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic CVI of the lower extremity. The BlueLeaf System is designed to form autogenous tissue leaflets from vein walls in the femoral and popliteal veins without the use of a permanent vascular implant for the treatment of CVI. Subjects meeting eligibility criteria will be enrolled and may be followed through 5 years post treatment.

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Eligibility criteria

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

Inclusion criteria

  • Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) grade 3 to 6
  • Failed compression therapy of at least 6 months' duration
  • Deep system venous reflux characterized by >1 second reflux time
  • Presence of at least one target site within the target vessel
  • Exclusion criteria

  • Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms
  • Deep venous intervention in the target limb or outflow vessels within 6 months of consent
  • Significant peripheral arterial disease with an ankle-brachial index of <0.50 or with incompressible vessels
  • Acute deep venous thrombosis (DVT) within 3 months of consent
  • History of stroke within the last 6 months
  • Flow-limiting venous outflow obstruction central to the intended target sites
  • Insufficient inflow through the treatment vein upon manual augmentation
  • Chronic, diffuse, post-thrombotic femoropopliteal vein disease that, in the Investigator's opinion, would preclude venous valve formation or would inhibit flow through the treatment sites
  • Chronic renal insufficiency with creatinine level of ≥2mg/dL
  • Hemoglobin level <9.0 mg/dL
  • Platelet count <50,000 or >1,000,000 per mm3
  • Total white blood cell count <3,000/mm3
  • Pregnant or lactating female; positive pregnancy test, women of childbearing potential must be tested
  • Non-ambulatory patients
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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: 2017-11-02

    Primary completion: 2025-12-01

    Study completion finish: 2025-12-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT03216005

    Intervention or treatment

    DEVICE: BlueLeaf System

    Conditions

    • Chronic Venous Insufficiency

    Find a site

    Closest Location:

    Royal Prince Alfred

    Research sites nearby

    Select from list below to view details:

    • Royal Prince Alfred

      Camperdown, New South Wales, Australia

    • Prince of Wales

      Randwick, New South Wales, 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: BlueLeaf System
    • The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.
    DEVICE: BlueLeaf System
    • The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Percent decrease in reflux time (RT) in the primary treated vein segment from pre-procedure baseline to the 30-day follow-up imaging studyNot Specified30 days
    Freedom from target vessel deep venous thrombosis (DVT) at the 30-day follow-up imaging study.Not Specified30 days

    Secondary outcome

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    References

    Clinical Trials Gov: Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

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