Status:
TERMINATED
Care China-Diabetes
Lead Sponsor:
Johnson & Johnson Medical, China
Conditions:
Cardiovascular Disease
Diabetes
Eligibility:
All Genders
18-80 years
Brief Summary
This multicenter, prospective, observational registry will assess efficacy and safety outcomes associated with percutaneous coronary intervention (PCI) with implantation of the CYPHER Select™+ Sirolim...
Detailed Description
The study objective is to assess the incidences of major adverse cardiovascular events (MACE; defined as a composite of clinically driven target-lesion revascularization, cardiac death, any myocardial...
Eligibility Criteria
Inclusion
- Patients between the ages of 18 and 80 (inclusive) receiving CYPHER SELECT™+ Sirolimus-eluting Coronary Stent according to standard clinical practice when financially feasible
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
- Patient has diagnosis of diabetes or is diagnosed with it before or during the index procedure hospitalization based on disease diagnosis criteria
Exclusion
- Any contraindication to any of the following medications: aspirin, heparin, thienopyridines (clopidogrel/ticlopidine), stainless steel, contrast agents, or sirolimus
- An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment
- Cardiogenic shock
- Terminal illness with life expectancy \<1 year
- ST-segment elevation myocardial infarction within 7 days prior to the index procedure
- Any patient who received coronary stent(s) within 1 year
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
1603 Patients enrolled
Trial Details
Trial ID
NCT00938119
Start Date
August 1 2009
End Date
December 1 2012
Last Update
June 28 2013
Active Locations (46)
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1
Beijing Anzhen Hospital of the Capital University of Medical Science
Beijing, Beijing Municipality, China, 100029
2
General Hospital of Armed Police Forces
Beijing, Beijing Municipality, China, 100039
3
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
4
Beijing Tongren Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100730