Ignite Creation Date:
2025-12-17 @ 10:07 PM
Ignite Modification Date:
2025-12-23 @ 9:48 PM
Study NCT ID:
NCT00759681
Status:
None
Last Update Posted:
2013-01-31 00:00:00
First Post:
2008-09-23 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial
Sponsor:
None
Organization:
Study Overview
Official Title:
A Prospective, Multi-center, Randomized Study to Evaluate the Safety and Efficacy of ArterX Vascular Sealant.
Status:
None
Status Verified Date:
2012-12
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:
StEPS
Brief Summary:
To evaluate, during open vascular surgery, the safety and effectiveness of the ArterX™ Vascular Sealant when applied prophylactically. Application will be at synthetic vascular graft or patch to native vessel anastomosis prior to the restoration of full systemic circulation to achieve suture line sealing.
Detailed Description:
None
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?: