Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00497172
Status:
COMPLETED
Last Update Posted:
2010-02-04
First Post:
2007-07-04
Brief Title:
Diabetes Drug Eluting Sirolimus Stent Experience in Restenosis Trial
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
An Italian Multicenter Randomized Single Blind Study of the Sirolimus Eluting Stent in the Treatment Of Diabetic Patients With De Novo Coronary Artery Lesions
Status:
COMPLETED
Status Verified Date:
2010-02
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:
DESSERT
Brief Summary:
The main objective of this study is to assess the safety and effectiveness of the Sirolimus-eluting stent CYPHERTM andor updated version in reducing angiographic in-stent late loss in de novo native coronary lesions of diabetic patients as compared to the bare metal Bx SONIC balloon-expandable stent
The secondary objective is to assess cost-effectiveness expressed in incremental costlife year gained or costquality adjusted life year gained at different time points 8 months 1 year
The secondary objective is to assess cost-effectiveness expressed in incremental costlife year gained or costquality adjusted life year gained at different time points 8 months 1 year
Detailed Description:
This is a multicenter 11 centers prospective randomized single blind study This study has a 2-arm design assessing the safety and effectiveness of the Sirolimus-eluting stent CYPHERTM andor updated version to the bare metal Bx SONICTM stent A total of 250 patients will be entered in the study and will be randomized on a 11 basis Patients who meet the eligibility criteria will be either randomized to the Sirolimus-eluting stent or the bare metal Bx SONIC stent The investigator cannot be blind because the outer appearance of the system for the implant of the Sirolimus-eluting stent differs from that of the bare metal stent and will therefore immediately be recognized by the surgeon However the patient will not know which stent will be implanted Patients will be followed at 30 days 9 and 12 months post-procedure with all patients undergoing repeat angiography at 8 months Additionally medical costs associated with the index hospitalization and length of stay and repeat hospitalizations and costs associated with other relevant medical resource use during the 1 year follow-up period will be collected and analyzed
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