Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 12:33 AM
Study NCT ID:
NCT04580160
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2020-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System
Sponsor:
Vesper Medical, Inc.
Organization:
Study Overview
Official Title:
Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System
Status:
COMPLETED
Status Verified Date:
2025-01
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:
VIVID
Brief Summary:
This is a prospective, multi-center, single-arm, non-blinded clinical trial designed to investigate the safety and efficacy of the Vesper DUO Venous Stent System as compared to a pre-defined performance goal (PG) established from published, peer reviewed scientific literature related to stenting of iliofemoral venous outflow obstructions.
Detailed Description:
None
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?: