Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-08 @ 2:45 PM
Study NCT ID:
NCT03216005
Status:
RECRUITING
Last Update Posted:
2021-09-10
First Post:
2017-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System
Sponsor:
Intervene, Inc.
Organization:
Study Overview
Official Title:
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System
Status:
RECRUITING
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INFINITE-OUS
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: