Efficacy and Safety of Firebird 2 Stent in Treatment of Complex Coronary Lesions in Diabetes

Launched by XIJING HOSPITAL · Dec 8, 2010

Keywords

ClinConnect Summary

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 treatment of complex coronary lesions in diabetes. As planned, about 57 research centers all over China, Latin America and Asia-Pacific areas will be involved and, 1300 patients will be enrolled into this research. The implanted stents must all be Firebird2 cobalt-chromium alloyed sirolimus-eluting stent. The patient enrollment will last for 12 months. Clinical follow-up will be done respectively ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.