NCT05047302

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Intervene, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

STUDY DESIGN: The Study is a prospective, non-randomized study to evaluate participants treated with the BlueLeaf System for the restoration of deep venous competence for the treatment of symptomatic chronic venous insufficiency (CVI). STUDY OVERVIEW: Potential participants who pass pre-screening and are willing to participate in the study will be asked to sign the study Informed Consent Form before any study-specific tests or procedures are performed or for any study specific evaluations not considered standard of care that need to be performed to assess eligibility. Eligible participants may undergo the index procedure. Adverse events are assessed. All participants enrolled in the study are evaluated at pre-specified timepoints. STUDY POPULATION: Patients with CVI and a Clinical Etiological Anatomical Pathophysiological (CEAP) classification of 4, 5, or 6. STUDY ENROLLMENT: Up to 50 subjects will be enrolled.

Conditions

• Chronic Venous Insufficiency

Interventions

Type	Name	Description
DEVICE	BlueLeaf Procedure	The device is intended to form autogenous tissue leaflets from vein walls without the use of a permanent vascular implant.

Timeline

• Start date: 2022-10-01
• Primary completion: 2025-11-01
• Completion: 2026-11-01
• First posted: 2021-09-17
• Last updated: 2025-08-05