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Clinical trial No longer in our active list Interventional Ages 18 and up

Treatment of chronic venous insufficiency using the BlueLeaf System

Official title: Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

Run by Intervene, Inc. · NCT03216005 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing a new device called the BlueLeaf System to see if it can help people with chronic venous insufficiency feel better by improving their vein function without using permanent implants.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment15 (estimated)
SponsorIntervene, Inc.
Industry-sponsored
Locations5 sites (Camperdown, New South Wales and 4 other locations)
Trial IDNCT03216005 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals with symptomatic CVI, specifically those with CEAP grades 3 to 6 who have not responded to compression therapy.

Probably not a fit

Patients with untreated significant superficial venous incompetence or recent deep venous interventions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of the BlueLeaf System, which aims to restore venous competence in patients suffering from symptomatic chronic venous insufficiency (CVI). It is a prospective, non-randomized, multicenter pre-market feasibility study that focuses on forming autogenous tissue leaflets from vein walls in the femoral and popliteal veins without using permanent vascular implants. Eligible subjects will be treated and followed for up to five years post-treatment to assess outcomes.

Why it matters

Potential benefit: If successful, this treatment could significantly improve symptoms and quality of life for patients with chronic venous insufficiency.

How similar studies have gone: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel intervention.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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;

Where it's running

  • Royal Prince Alfred
    Camperdown, New South Wales, Australia     Recruiting
  • Prince of Wales
    Randwick, New South Wales, Australia     Recruiting
  • Vancouver Coastal Health Research Institute
    Vancouver, British Columbia, Canada     Recruiting
  • Auckland City Hospital
    Auckland, New Zealand     Recruiting
  • Clinical Trials New Zealand Ltd
    Hamilton, New Zealand     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Chronic Venous Insufficiency 4Intervene, Inc. 2
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.