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Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System — INFINITE-OUS  

Chronic Venous Insufficiency Clinical Trial

Official title:
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

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).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03216005
Study type Interventional
Source Intervene, Inc.
Contact Tracy Roberts
Phone 303-396-4603
Email tracy@intervene-med.com
Status Recruiting
Phase N/A
Start date November 2, 2017
Completion date December 2025
View Details
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