Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-03-11 @ 9:03 PM
Study NCT ID:
NCT02136004
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2014-05-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System
Sponsor:
Rex Medical
Organization:
Study Overview
Official Title:
The Closer Trial: A Multi-center, Prospective, Single Arm Trial to Evaluate the Safety and Efficacy of the Rex Medical Closer Vascular Sealing System (VSS) for the Management of the Femoral Arteriotomy After Percutaneous Endovascular Procedures
Status:
COMPLETED
Status Verified Date:
2017-09
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:
Closer
Brief Summary:
The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.
Detailed Description:
The objective of the trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System (VSS) in sealing femoral arterial access sites and providing reduced times to hemostasis (TTH) compared with performance goals at the completion of diagnostic or interventional procedures performed through 5, 6 or 7 Fr procedural sheaths. This study will be considered a success (from a statistical perspective) if it meets both the Closer VSS superiority goal for the primary effectiveness analysis and the Closer VSS performance goal for the primary safety analysis.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: