Efficacy and Safety of Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent in Treatment of Complex Coronary Lesions in Diabetes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Cumulative major adverse cardiovascular events（MACE）
研究概览
简要总结
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.
详细描述
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 for 30 days, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months. All quitted patients during the study will not be replaced with any substitutes, but categorized in the enrollment failure column. The researcher must state clear the reason of nonenrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Cumulative major adverse cardiovascular events（MACE）
时间窗: 12-month
including cardiac death, Q-wave or Non-Q-wave MI,ischemia driven Target Lesion Revascularization (TLR)
次要结局
- Post-procedure MACE(30 days, 6/12/18/24/30/36 months.)
- Cumulative stent thrombosis(12 months)
- Ischemia-driven target vessel revascularization(TVR)(12 months)
- Stroke(12 months)