Status:
UNKNOWN
Efficacy and Safety of Firebird 2 Stent in Treatment of Complex Coronary Lesions in Diabetes
Lead Sponsor:
Xijing Hospital
Collaborating Sponsors:
Air Force Military Medical University, China
Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this study is to assess the long-term efficacy and safety of Firebird2 Cobalt-Chromium（CoCr）-alloyed sirolimus-eluting stent in treatment of complex lesions in diabetes.
Detailed Description
This clinical trial is an international multi-center prospective clinical registry research, for evaluating the efficacy and safety of Firebird 2 cobalt-chromium alloyed sirolimus-eluting stent in tre...
Eligibility Criteria
Inclusion
- Definitely diagnosed type 2 DM either before or during the current hospitalization and with complex coronary lesions
- The coronary lesion is complied with the definition of complex type. (defined by protocol)
- The investigator admitted patients which are suitable for implanting Firebird2 CoCr-alloyed Sirolimus-eluting stent(SES)
- Patient or his/ her legal supervisor are provided with informed consents.
Exclusion
- Women during pregnancy and breast-feeding;
- ST-segment elevated MI occurred within 1 week;
- Graft lesion after the coronary artery bypass graft(CABG) operation;
- Patient with other brand of stent implanted;
- LVEF ≤ 35%;
- Renal insufficiency before operation (Serum creatinine ≥ 177umol/L)
- Impaired fasting glucose（6.0mmol/L～7.0mmol/L）or impaired glucose tolerance（OGTT 2h blood glucose 7.8mmol/L～11.1mmol/L）patient;
- Recent PCI within 6 months or previous intravascular radiotherapy;
- Predicted life span is less than 12 months;
- Patient allergic to the following materials: aspirin, heparin, Clopidogrel, CoCr alloy, contrast agent or sirolimus.
- Recent participation of trial medication or other device study without endpoints completion or it is clinically interfering FIRE2-DIABETES study endpoints.
- Considered by other investigators unsuitable for implanting Firebird2 CoCr-alloyed SES
- Patients could not obey the study rules, such as not understanding the study manner, scope or its outcome, not cooperative, not providing the informed consent, not accepting follow-up, not finishing the whole study procedure.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT01257373
Start Date
April 1 2010
End Date
April 1 2013
Last Update
December 30 2010
Active Locations (1)
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1
Department of cardiology of Xijing Hospital, Fourth Military Medical University
Xi'an, Shannxi, China, 710032