Ignite Creation Date:
2024-05-05 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00714623
Status:
COMPLETED
Last Update Posted:
2012-12-24
First Post:
2008-07-09
Brief Title:
The SCRIPPS DES REAL WORLD Registry
Sponsor:
Paul S Teirstein MD
Organization:
Scripps Health
Study Overview
Official Title:
A Prospective Registry for the Use of CypherTM Sirolimus-Eluting Stents In Patients With Coronary Artery Disease Treated With Percutaneous Coronary Interventions at Scripps Clinic
Status:
COMPLETED
Status Verified Date:
2012-12
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:
This study is a prospective non-randomized open-label registry of consecutive patients with CAD treated by stent-assisted PCI using at least one CypherTM stent Up to 1000 pts will be included in the registry The registry is conducted for the evaluation of the impact of CypherTM Sirolimus-eluting stent implantation in the real world of interventional cardiology Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study specific procedures Consecutive patients treated with the use of the CypherTM stent will be included in the registry Baseline and post-procedure blood samples will be used to perform platelet function analysis using the Accumetrics Ultegra RPFA Rapid Platelet Function Assay
All patients will be followed from enrollment through the hospital discharge for any clinically significant event death myocardial infarction TLR TVR major or minor bleeding A follow-up telephone assessment of death myocardial infarction revascularization and medical treatment will be conducted by experienced research personnel at 30 days 6 months 1 year and at least 2 years All site reported deaths myocardial infarctions and revascularizations will be adjudicated by an independent Clinical Events Committee for all 1000 patients enrolled in the trial An interim analysis of the first 750 patients will be conducted and data forwarded to FDA
All patients will be followed from enrollment through the hospital discharge for any clinically significant event death myocardial infarction TLR TVR major or minor bleeding A follow-up telephone assessment of death myocardial infarction revascularization and medical treatment will be conducted by experienced research personnel at 30 days 6 months 1 year and at least 2 years All site reported deaths myocardial infarctions and revascularizations will be adjudicated by an independent Clinical Events Committee for all 1000 patients enrolled in the trial An interim analysis of the first 750 patients will be conducted and data forwarded to FDA
Detailed Description:
None
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