Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Intervene, Inc.
- Enrollment
- 14
- Locations
- 10
- Primary Endpoint
- Freedom from target vessel deep venous thrombosis (DVT) at the 30-day follow-up imaging study.
Study Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
BlueLeaf System
The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.
Intervention: BlueLeaf System (Device)
Outcomes
Primary Outcomes
Freedom from target vessel deep venous thrombosis (DVT) at the 30-day follow-up imaging study.
Time Frame: 30 days
Percent decrease in reflux time (RT) in the primary treated vein segment from pre-procedure baseline to the 30-day follow-up imaging study
Time Frame: 30 days
Primary Effectiveness: Change in Reflux Time (RT) in the Primary Treated Vein Segment
Time Frame: Baseline, 7-day, 30-day
Change in reflux time (reported as % change) in the primary treated vessel from pre-procedure baseline compared to the 30-day follow-up
Primary Safety: Number of Participants With Target Vessel Deep Venous Thrombosis (DVT)
Time Frame: 30-day post-procedure
Rates (count) of participant with DVTs in the target vessel at the 30-day time point - analyzed for subjects that completed the 30-day follow-up visit
Secondary Outcomes
- Number of Participants With Target Vessel Deep Venous Thrombosis (DVT) in the Primary Treated Vein Segment(90-day, 210-day)
- Change in Reflux Time (RT) in the Primary Treated Vein Segment(90-day, 210-day)