Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322569
Status:
COMPLETED
Last Update Posted:
2013-03-06
First Post:
2006-05-04
Brief Title:
A Randomized Multi-Center Study of the Pimecrolimus-Eluting and PimecrolimusPaclitaxel-Eluting Coronary Stent Systems GENESIS
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
A Randomized Multi-Center Study of the Pimecrolimus-Eluting Corio and PimecrolimusPaclitaxel-Eluting Coronary Stent System SymBio in Patients With De Novo Lesions of the Native Coronary Arteries
Status:
COMPLETED
Status Verified Date:
2013-03
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:
None
Brief Summary:
To demonstrate non-inferiority in 6-month angiographic in-stent late lumen loss of the pimecrolimus-eluting coronary stent Corio compared to the CoStar coronary stent control arm and the dual pimecrolimuspaclitaxel-eluting Symbio coronary stent compared to the CoStar coronary stent control arm for the treatment of single de novo lesions 25 mm in length in native coronary arteries 25 - 35 mm in diameter
Detailed Description:
This study is designed to evaluate 6 month in-stent late lumen loss of the 1 Corio pimecrolimus-eluting coronary stent system and the 2 SymBio dual pimecrolimuspaclitaxel-eluting coronary stent system compared to the CoStar Paclitaxel-Eluting Coronary Stent System control arm
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