Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT01025869
Status:
TERMINATED
Last Update Posted:
2016-01-12
First Post:
2009-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Clinical Evaluation of the Cinatra™ Corolimus-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries
Sponsor:
Atrium Medical Corporation
Organization:
Study Overview
Official Title:
The Clinical Evaluation of the Cinatra™ Corolimus-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries
Status:
TERMINATED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated following completion of 2 year time point: Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VANTAGE-1
Brief Summary:
To investigate the safety and efficacy of the Cinatra™ Corolimus Drug Eluting Stent for the treatment of de novo lesions in native coronary arteries.
Detailed Description:
This is a single-arm, multicentre pilot study designed to provide an indication of the effectiveness and safety of the Cinatra™ Corolimus Eluting Coronary Stent System. The primary endpoint to be evaluated in this study is late lumen loss (in-stent) at 6 months post-procedure as measured by QCA in the 30 participants undergoing angiography at this timepoint. Late lumen loss is defined as the difference between the post-index procedure minimal lumen diameter (MLD) and the follow-up MLD.
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?: