Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT00689767
Status:
TERMINATED
Last Update Posted:
2013-04-17
First Post:
2008-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COronary Native Artery First in Man Investigation of ISA 247 Elution to Prevent Restenotic Mechanisms (CONFIRM 1)
Sponsor:
Atrium Medical Corporation
Organization:
Study Overview
Official Title:
COronary Native Artery First in Man Investigation of ISA 247 Elution to Prevent Restenotic Mechanisms
Status:
TERMINATED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated ahead of schedule after completion of the 3-year follow-up time point due to Sponsor decision.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONFIRM 1
Brief Summary:
This First In Man study is a prospective, multicentre, single blind, randomized, controlled clinical trial of the CINATRA™ ISA 247 Coated Coronary Stent System as compared to the CINATRA™ Coronary Stent System. The study will enroll up to 100 evaluable patients at up to 7 sites. Clinical follow up will occur at 1 month, 6 months, and 1, 2, 3, 4 and 5 years post procedure. Repeat angiography and IVUS will be performed at the 6 month follow up time point for all subjects.
Detailed Description:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Application #: 2008-001347-20 | None | None | View |