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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,300
Firebird2 CoCr-alloyed sirolimus-eluting stent system is the 2nd generation of drug-eluting stent(DES). It was registered successfully on Jan. 16, 2009 in China. This stent is based with a CoCr alloyed metal platform. The length is from 13-33mm, the diameter is from 2.5mm-4.0mm.
Department of cardiology of Xijing Hospital, Fourth Military Medical University
Xi'an, Shannxi, China
RECRUITINGCumulative major adverse cardiovascular events(MACE)
including cardiac death, Q-wave or Non-Q-wave MI,ischemia driven Target Lesion Revascularization (TLR)
Time frame: 12-month
Post-procedure MACE
Time frame: 30 days, 6/12/18/24/30/36 months.
Cumulative stent thrombosis
By Academic Research Consortium(ARC) definition (definite and probable)
Time frame: 12 months
Ischemia-driven target vessel revascularization(TVR)
The repeated intervention therapy or surgical bypass grafting to any segment of the target vessel is called target vessel revascularization. Target vessel means the entire major coronary arteries proximal or distal to the target lesion, including all upstream and downstream branches and the lesion itself
Time frame: 12 months
Stroke
including Ischemic and hemorrhagic stroke
Time frame: 12 months
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