Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130546
Status:
COMPLETED
Last Update Posted:
2009-05-15
First Post:
2005-08-11
Brief Title:
Intra-Individual Comparison of Sirolimus and Paclitaxel Coated Stent FRE-RACE Study
Sponsor:
University Hospital Freiburg
Organization:
University Hospital Freiburg
Study Overview
Official Title:
A Prospective Randomized Intra-Individual Study With the Sirolimus Coated Cypher SelectTM and the PaclitaxelTM Coated Express Balloon Expandable Stents for the Treatment of Patients With Two de Novo Native Coronary Artery Lesions
Status:
COMPLETED
Status Verified Date:
2009-05
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:
The main objective of this study is to assess the safety and effectiveness of the Sirolimus eluting Cypher SelectTM stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the TAXUSTM Paclitaxel-eluting stent in patients presenting with two or more coronary artery stenoses prospective randomized intra-individual comparison
Detailed Description:
This is a prospective 2 arm randomized multicenter Phase III study 6 centers
A total of 110 patients with at least two de novo native coronary artery lesions lesion A lesion B 30 mm in length and 225 mm to 30 mm in diameter by visual estimate will be enrolled Patients will be randomized for implantation of the sirolimus eluting Cypher SelectTM Balloon-Expandable Stent or to the TAXUSTM Paclitaxel-eluting stent for lesion A and B
A total of 110 patients with at least two de novo native coronary artery lesions lesion A lesion B 30 mm in length and 225 mm to 30 mm in diameter by visual estimate will be enrolled Patients will be randomized for implantation of the sirolimus eluting Cypher SelectTM Balloon-Expandable Stent or to the TAXUSTM Paclitaxel-eluting stent for lesion A and B
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