Treatment of chronic venous insufficiency using the BlueLeaf System

Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Intervene, Inc. (Industry-sponsored)
• Locations: 5 sites (Camperdown, New South Wales and 4 other locations)
• Trial ID: NCT03216005 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

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

Eligibility 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 this trial is running

Camperdown, New South Wales and 4 other locations

• 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

• Study coordinator: Tracy Roberts

Conditions Chronic Venous Insufficiency