Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481741
Status:
COMPLETED
Last Update Posted:
2009-07-31
First Post:
2007-06-01
Brief Title:
Study of the SafeSealTM Hemostasis Patch Following Percutaneous Coronary Artery and Peripheral Vascular Interventions
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
A Prospective Randomized Controlled Efficacy and Safety Trial of the SafeSeal Hemostasis Patch Compared to Manual Compression for Achieving Vascular Hemostasis Following Percutaneous Coronary and Peripheral Intervention
Status:
COMPLETED
Status Verified Date:
2009-07
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:
None
Brief Summary:
We seek to determine if the use of the SafeSealTM topical hemostasis patch is associated with reductions in time to hemostasis and time to ambulation compared to standard manual compression after arterial sheath removal following percutaneous coronary and peripheral intervention We further seek to assess the safety of the SafeSeal patch compared to manual compression
Detailed Description:
A variety of topical hemostasis pads containing procoagulant materials are currently available to accelerate hemostasis after removal of the arterial introducer sheath following coronary and peripheral arterial angioplasty procedures The effectiveness and safety of these pads however remains poorly understood A total of 150 patients undergoing coronary or peripheral vascular angioplasty through a 6 French arterial sheath will be randomized to sheath removal using manual compression alone or manual compression combined with use of the SafeSealTM hemostasis patch Sheaths will be removed at an activated clotting time ACT of 250 seconds and patients will be kept at bedrest for 2 hours after hemostasis is achieved The primary endpoint will be time to hemostasis Secondary endpoints witll include time to ambulation and frequency of bleeding complications
Study Oversight
Has Oversight DMC:
None
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?:
None