Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System
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).
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.
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT03216005
Intervention or treatment
DEVICE: BlueLeaf System
Conditions
- Chronic Venous Insufficiency
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Research sites nearby
Closest Location:
Royal Prince Alfred
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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Who is running the clinical trial?
Intervene, Inc.
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/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: BlueLeaf System
| Device: BlueLeaf System |
What is the study measuring?
Primary Outcome
| Measure | Description | 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 study | Not Specified | 30 days |
| Freedom from target vessel deep venous thrombosis (DVT) at the 30-day follow-up imaging study. | Not Specified | 30 days |
Secondary Outcome
References
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