To document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a real-world patient population requiring stent implantation.
The Resolute stent is designed to support the approach of delivering drug to the coronary arterial tissue over a longer period of time than that offered by current approved DES products. This method of prolonged drug elution may address the need to control local vascular neointimal proliferation in patients with complex lesions for extended therapeutic effect. The purpose of this multi-center trial is to investigate the clinical safety and efficacy of the Endeavor Resolute drug-eluting stent in every-day patients, like stable and unstable patients with single or multi-vessel disease and/or complex lesions. Patients should be treated according to normal hospital routine practice and in line with the applicable guidelines on percutaneous coronary interventions and the Instructions For Use of the device. 1800 patients will be enrolled from China at approximately 40 centers where Endeavor Resolute stent is commercially available.
Study Type
OBSERVATIONAL
Enrollment
1,800
Beijing Fumwai Hospital
Beijing, China
Peiking University People's Hospital
Beijing, China
Fujian Medical University Union Hospital
Fuzhou, China
Guangdong Provincial People's Hospital
Guangdong, China
Target lesion failure (TLF)
Target lesion failure (TLF): a composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods at 1 year.
Time frame: 12m
Overall stent thrombosis
Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition, at 1 year.
Time frame: 12m
Device success, Lesion success, Procedural success
Time frame: At the end of the index procedure or during hospital stay
TLF
Target lesion failure (TLF): a composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods will be assessed at 30 days, 6 months, 2 year, 3 year, 4 year and 5 year
Time frame: 30 days, 6 months, 2 year, 3 year, 4 year and 5 year
All deaths (cardiac, vascular and non-cardiovascular)
Time frame: 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Stent thrombosis rate
defined as definite, probable, possible, and overall stent thrombosis (according to ARC definition)
Time frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Myocardial infarction
Q wave and non-Q wave MI
Time frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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Nanjing First Hospital
Nanjing, China
Wuhan Asia Heart Hospital
Wuhan, China
Revascularization
target lesion and target vessel revascularization (TLR and TVR)
Time frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Significant bleeding complications and stroke
hemorrhagic in nature
Time frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Target vessel failure (TVF)
a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization
Time frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Major adverse cardiac events (MACE)
a composite endpoint of death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or repeat target lesion revascularization (clinically driven/clinically indicated) by percutaneous or surgical methods
Time frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year