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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
Exclusion criteria
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
TREATMENT
Phase
NA
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
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
Primary Outcome Measure | Primary Outcome Description | Primary 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 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
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