Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

Not Applicable

Recruiting

• Conditions: Chronic Venous Insufficiency
• Interventions: Device: BlueLeaf System

• Registration Number: NCT03216005
• Lead Sponsor: Intervene, Inc.

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 Timeline

• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-12
• Study Start: 2017-11-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-10
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BlueLeaf System	BlueLeaf System	The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.

Primary Outcome Measures

Name	Time	Method
Freedom from target vessel deep venous thrombosis (DVT) at the 30-day follow-up imaging study.	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	30 days

Trial Locations

Locations (5)

Clinical Trials New Zealand Ltd; 🇳🇿 Hamilton, New Zealand

Prince of Wales; 🇦🇺 Randwick, New South Wales, Australia

Royal Prince Alfred; 🇦🇺 Camperdown, New South Wales, Australia

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Vancouver Coastal Health Research Institute; 🇨🇦 Vancouver, British Columbia, Canada