Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232830
Status:
COMPLETED
Last Update Posted:
2009-09-16
First Post:
2005-10-04
Brief Title:
The Study to Assess AMI Treated With Balloon Angioplasty
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
Trial to Assess the Use of the Cypher TM Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty
Status:
COMPLETED
Status Verified Date:
2009-04
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:
TYPHOON
Brief Summary:
The main objective of this study is to assess the effectiveness and safety of the CYPHER CYPHER SELECT Sirolimus-eluting stent in reducing the occurrence of a composite endpoint of target vessel failure TVF in subjects treated for acute myocardial infarction as compared to a bare metal stent
Detailed Description:
This is an international multicenter up to 52 sites randomized single-blind study in patients with an acute myocardial infarction treated with the CYPHER Sirolimus-eluting stent as compared to the bare stents
Patients with de novo native coronary artery lesions will be treated with the CYPHER Sirolimus-eluting stent or a bare stent Subjects will be followed at 30 days 6 months and at 1 3 4 and 5 years post-procedure 200 subjects will have an angiographic follow-up at 8 months
Patients with de novo native coronary artery lesions will be treated with the CYPHER Sirolimus-eluting stent or a bare stent Subjects will be followed at 30 days 6 months and at 1 3 4 and 5 years post-procedure 200 subjects will have an angiographic follow-up at 8 months
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