Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,800
- 试验地点
- 6
- 主要终点
- Target lesion failure (TLF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient must meet all of the following criteria to be eligible for treatment in the trial:
- •Age ≥ 18 years or minimum age as required by local regulations
- •The patient is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute stent and the Declaration of Helsinki
- •The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form
- •Intention to electively implant at least one Resolute stent
- •The patient is willing and able to cooperate with study procedures and required follow up visits
排除标准
- •Patients will be excluded from the trial if any of the following criteria are met:
- •Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, bivalirudin, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. Biolinx), zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative, or contrast media
- •Women with known pregnancy or who are lactating
- •High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- •Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current trial requirements
- •Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
- •Previous enrollment in the Resolute China Registry
结局指标
主要结局
Target lesion failure (TLF)
时间窗: 12m
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.
次要结局
- Device success, Lesion success, Procedural success(At the end of the index procedure or during hospital stay)
- TLF(30 days, 6 months, 2 year, 3 year, 4 year and 5 year)
- Revascularization(at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year)
- Target vessel failure (TVF)(at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year)
- Overall stent thrombosis(12m)
- Stent thrombosis rate(at 30 days, 6 months, 1 year, 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)
- Myocardial infarction(at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year)
- Significant bleeding complications and stroke(at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year)
- Major adverse cardiac events (MACE)(at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year)