Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232765
Status:
COMPLETED
Last Update Posted:
2009-09-16
First Post:
2005-10-03
Brief Title:
Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions SIRIUS
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Study of the Sirolimus-Coated BX VELOCITYTM Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions
Status:
COMPLETED
Status Verified Date:
2009-09
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-coated Bx VELOCITYTM stent in reducing target vessel failure in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITYTM balloon-expandable stent Both stents are mounted on the Raptorâ over-the-wire OTW Stent Delivery System
Detailed Description:
This is a multicenter 55 sites prospective 2-arm randomized double-blind study designed to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITYTM stent as compared to the uncoated Bx VELOCITYTM stent A total of 1100 patients will be entered in the study and will be randomized on a 11 basis Patients with de novo native coronary artery lesions 15mm and 30mm in length and 250mm to 35mm in diameter by visual estimate who meet all eligibility criteria will be either randomized to the sirolimus-coated Bx VELOCITYTM stent or the uncoated Bx VELOCITYTM stent Patients will be followed at 30 days 3 6 9 and 12 months and 2 3 4 5 6 7 and 8 years post-procedure with approximately 850 patients having repeat angiography at 8 months A subset of approximately 17 centers will participate in an intravascular ultrasound IVUS sub study in which all patients at these centers will be enrolled in the sub study Additionally data will be collected for a medical economic analysis These data will include costs associated with the index hospitalization and length of stay and rehospitalizations during the 12-month follow-up period This is a single lesion treatment study Patients who have had interventions of other lesions within 30 days of the study procedure or have interventions planned after the index procedure are excluded It is anticipated that the total length of the study will be 101 months 5 months to complete patient enrollment and 8 years for follow-up
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