NCT04225806

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Intervene, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Chronic Venous Insufficiency (CVI)
• Deep Vein Reflux

Interventions

Type	Name	Description
DEVICE	BlueLeaf® Endovenous Valve Formation System (BlueLeaf System)	The BlueLeaf System is a single-use, disposable device designed to modify the vein wall to form one or more functional autogenous valves to improve the hemodynamics of the deep venous system treated.

Timeline

• Start date: 2020-02-13
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2020-01-13
• Last updated: 2025-08-19
• Results posted: 2025-08-19

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study