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

Chronic Venous Insufficiency (CVI) Clinical Trial

Official title: Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-US)

Status Terminated

Clinical Trial Summary

Prospective, non-randomized, multicenter pre-market early feasibility study (EFS) to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic CVI of the lower extremity

Clinical Trial Description

The purpose of this early feasibility study is to provide information on the BlueLeaf System for the formation of one or more autogenous vein valves constructed from the vein wall of the femoral and/or popliteal vein, in subjects with CVI and who meet the specified eligibility criteria. In particular, the safety and technical feasibility of the procedure will be validated in patients in the United States, including the procedural steps, operator technique, and subject characteristics. The study will assess the safety and effectiveness of the study device acutely and through 5 years. ;

Related Conditions & MeSH terms

• Chronic Venous Insufficiency (CVI)
• Deep Vein Reflux
• Venous Insufficiency

• NCT number: NCT04225806
• Study type: Interventional
• Source: Intervene, Inc.
• Status: Terminated
• Phase: N/A
• Start date: February 13, 2020
• Completion date: September 30, 2023