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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12m |
| Measure | Description | Time Frame |
|---|---|---|
| Overall stent thrombosis | Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition, at 1 year. | 12m |
| Device success, Lesion success, Procedural success |
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Inclusion Criteria:
Patient must meet all of the following criteria to be eligible for treatment in the trial:
Exclusion Criteria:
Patients will be excluded from the trial if any of the following criteria are met:
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Patients suitable for drug-eluting stent implantation according to the applicable guidelines on percutaneous coronary interventions and the Instructions for Use of the Resolute Zotarolimus-Eluting Coronary Stent System.
All consecutive patients eligible for drug-eluting stent implantation with the elective use of the Resolute stent in one or more target lesions are candidates to be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Shubin Qiao, MD | Fu Wai Hospital, Beijing, China | Principal Investigator |
| Jiyan Chen, MD | Guangdong Provincial People's Hospital | Principal Investigator |
| Lianglong Chen, MD | Fujian Medical University Union Hospital | Principal Investigator |
| Shaoliang Chen, MD | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Weimin Wang, MD | Peiking University People's Hospital | Principal Investigator |
| Guoying Zhu, MD | Wuhan Asia Heart Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Fumwai Hospital | Beijing | 100000 | China | |||
| Peiking University People's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24365120 | Result | Qiao S, Chen L, Chen S, Wang W, Zhu G. One-year outcomes from an all-comers chinese population of patients implanted with the resolute zotarolimus-eluting stent. Am J Cardiol. 2014 Feb 15;113(4):613-20. doi: 10.1016/j.amjcard.2013.10.042. Epub 2013 Nov 23. |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D001157 | Arterial Occlusive Diseases |
| D003327 | Coronary Disease |
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| 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 | 30 days, 6 months, 2 year, 3 year, 4 year and 5 year |
| All deaths (cardiac, vascular and non-cardiovascular) | 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) | 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 | at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year |
| Revascularization | target lesion and target vessel revascularization (TLR and TVR) | at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year |
| Significant bleeding complications and stroke | hemorrhagic in nature | 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 | 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 | at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year |
| Beijing |
| 100044 |
| China |
| Fujian Medical University Union Hospital | Fuzhou | 350001 | China |
| Guangdong Provincial People's Hospital | Guangdong | 510000 | China |
| Nanjing First Hospital | Nanjing | 210006 | China |
| Wuhan Asia Heart Hospital | Wuhan | 430022 | China |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |