Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-02 @ 1:18 AM
Study NCT ID:
NCT05468957
Status:
WITHDRAWN
Last Update Posted:
2025-12-18
First Post:
2022-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Perclose to Statseal in Conjunction With Perclose in Femoral 6 French Arteriotomy Closure
Sponsor:
University of California, Los Angeles
Organization:
Study Overview
Official Title:
A Prospective Randomized Study Comparing Time to Ambulation, Time to Hemostasis and Safety Using a Closure Device Alone an in Conjunction With a Potassium Ferrate Pad Following Transfemoral Catheterization
Status:
WITHDRAWN
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Initiating PI left our institution.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transfemoral procedures with 6 French Access. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transfemoral procedures. It is believed that the use of both devices in combination compared to the Perclose alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that patients would need to lay flat.
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?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: