Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

Chronic Venous Insufficiency Clinical Trial

— INFINITE-OUS  

Official title:

Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03216005
• Other study ID #: CLN 003
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2017
• Est. completion date: December 2025

Study information

• Verified date: September 2021
• Source: Intervene, Inc.
• Contact: Tracy Roberts
• Phone: 303-396-4603
• Email: tracy[@]intervene-med.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency

Intervention

Device:
• BlueLeaf System
The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.

Locations

Country	Name	City	State
Australia	Royal Prince Alfred	Camperdown	New South Wales
Australia	Prince of Wales	Randwick	New South Wales
Canada	Vancouver Coastal Health Research Institute	Vancouver	British Columbia
New Zealand	Auckland City Hospital	Auckland
New Zealand	Clinical Trials New Zealand Ltd	Hamilton

Sponsors (1)

Lead Sponsor	Collaborator
Intervene, Inc.

Countries where clinical trial is conducted

Australia,  Canada,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Freedom from target vessel deep venous thrombosis (DVT) at the 30-day follow-up imaging study.		30 days