Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00388934
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2006-10-16
Brief Title:
Comparison of Cypher Select and Taxus Express Coronary Stents
Sponsor:
Aarhus University Hospital Skejby
Organization:
Aarhus University Hospital Skejby
Study Overview
Official Title:
Randomized Clinical Comparison of Cypher Select and Taxus Express Stent Implantation in Unselected Patients With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2007-05
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:
SORT-OUTII
Brief Summary:
Randomized nine months clinical comparison of implantation of Taxol eluting Taxus Express and Sirolimus eluting Cypher Select stents in non-selected patients with coronary artery disease
Detailed Description:
Design
Randomized open multicentre trial
Patients
1800 patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation
Inclusion criteria
Patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation
Signed informed consent
Exclusion criteria
Participation in other stent studies
Randomization
Implantation of Taxus Express og Cypher Select stents
Primary end-point
Combined end-point of cardiac death new revascularization PCI or CABG or myocardial infarction after nine months
Secondary end-points
Total death after nine months
Cardiac death after nine months
Myocardial infarction after nine months
Index vessel myocardial infarction after nine months
Target lesion revascularization
Target vessel revascularization
Stent thrombosis after nine months
End-point evaluation
End-points will be adjudicated by an independent end-point committee
Randomized open multicentre trial
Patients
1800 patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation
Inclusion criteria
Patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation
Signed informed consent
Exclusion criteria
Participation in other stent studies
Randomization
Implantation of Taxus Express og Cypher Select stents
Primary end-point
Combined end-point of cardiac death new revascularization PCI or CABG or myocardial infarction after nine months
Secondary end-points
Total death after nine months
Cardiac death after nine months
Myocardial infarction after nine months
Index vessel myocardial infarction after nine months
Target lesion revascularization
Target vessel revascularization
Stent thrombosis after nine months
End-point evaluation
End-points will be adjudicated by an independent end-point committee
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