Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
Study NCT ID:
NCT01911403
Status:
TERMINATED
Last Update Posted:
2019-02-19
First Post:
2011-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
AGIR Study: Angio-Seal in Interventional Radiology
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
Efficacy Superiority of Angio-Seal™ vs. Manual Compression in Interventional Radiology
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment rate.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AGIR
Brief Summary:
Clinical study in patients undergoing any intervention requiring vascular access to the femoral artery. The study compares Angio-Seal™ vs. Manual Compression with regard to control the vascular access.
It is designed to demonstrate superiority of the Angio-Seal™ with an unchanged risk-profile.
It is designed to demonstrate superiority of the Angio-Seal™ with an unchanged risk-profile.
Detailed Description:
Patients will have their puncture closure randomly performed by one of these approved methods: Angio-Seal™ Closure device or Manual Compression.
Patients will be enrolled in the study during 12 months, with a follow-up period of 2 weeks (± 1 week).
The randomization will be stratified according to the type of procedure.
Patients will be enrolled in the study during 12 months, with a follow-up period of 2 weeks (± 1 week).
The randomization will be stratified according to the type of procedure.
Study Oversight
Has Oversight DMC:
False
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?: