Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-30 @ 5:58 AM
Study NCT ID:
NCT04225806
Status:
TERMINATED
Last Update Posted:
2025-08-19
First Post:
2020-01-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-US)
Sponsor:
Intervene, Inc.
Organization:
Study Overview
Official Title:
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-US)
Status:
TERMINATED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Project suspended by Sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INFINITE-US
Brief 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.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: