NCT03216005

Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

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

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.

Conditions

• Chronic Venous Insufficiency

Interventions

Type	Name	Description
DEVICE	BlueLeaf System	The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.

Timeline

• Start date: 2017-11-02
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2017-07-12
• Last updated: 2021-09-10

Locations

5 sites across 3 countries: Australia, Canada, New Zealand

Regulatory

• FDA-regulated device study