Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232856
Status:
COMPLETED
Last Update Posted:
2008-04-30
First Post:
2005-10-04
Brief Title:
A Study of the Cypher SES to Treat Restenotic Native Coronary Artery Lesions
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
A Multi-Center Non-Randomised Study of the CYPHER Sirolimus-Eluting Stent in the Treatment of Patient With an in-Stent Restenotic Native Coronary Artery Lesion
Status:
COMPLETED
Status Verified Date:
2008-04
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:
TROPICAL
Brief Summary:
The main objective of this study is to assess the safety and effectiveness of the Cypher sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an in-stent restenotic native coronary artery lesion
Detailed Description:
This is a multicenter 11 sites non-randomized study Patients who meet the eligibility criteria will be treated with the Cypher sirolimus-eluting stent All patients will have a repeat angiography at six months post-procedure and will be additionally followed clinically at 1 6 and 9 months and up to 3 years The results of this study will be compared with the outcome of the GAMMA I II as the historical control
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