Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT00388934
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2006-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Cypher Select and Taxus Express Coronary Stents
Sponsor:
Aarhus University Hospital Skejby
Organization:
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:
True
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?: