A Randomized Controlled Trial of the Resolute Zotarolimus-Eluting Stent Versus the Taxus Liberte Paclitaxel-Eluting Stent for Percutaneous Coronary Intervention in a Real-World All-comer 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
- 400
- 试验地点
- 4
- 主要终点
- in-stent late lumen loss (LLL)
研究概览
简要总结
The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9 months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer patient population requiring stent implantation.
详细描述
This study is a prospective, multicenter, randomized, two-arm, open-label study, designed to assess the non-inferiority of Resolute stent compared to Taxus Liberte stent in in-stent late lumen loss.
The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9 months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer patient population requiring stent implantation.
This trial will be conducted at approximately 20 sites and will enroll up to 400 subjects, randomized to the Resolute stent and Taxus Liberte stent in a 1:1 ratio. Subjects will be randomized using an interactive voice response system (IVRS).
Due to the design characteristics of the devices, the study investigators and operators can not be blinded. However, the clinical event adjudication committee, consisting of cardiologists who are not participating in the study, will be blinded for the treatment arm of the subjects to avoid a potential bias in the adjudication process of events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 Taxus Liberte 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 or Taxus Liberte 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, 316L stainless steel, polymer coatings (e.g. Biolinx), zotarolimus, paclitaxel, 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 RCT
研究组 & 干预措施
Taxus Liberte Paclitaxel-Eluting Coronary Stent System
Subjects will be randomized to be treated with Taxus Liberte Paclitaxel-Eluting Coronary Stent System by an interactive voice response system (IVRS).
干预措施: Taxus Liberte Paclitaxel-Eluting Coronary Stent System (Device)
Medtronic Resolute (Zotarolimus-eluting stent)
Subjects will be randomized to be treated with Medtronic Resolute (Zotarolimus-eluting stent) by an interactive voice response system (IVRS).
干预措施: Resolute Zotarolimus-Eluting Coronary Stent System (Device)
结局指标
主要结局
in-stent late lumen loss (LLL)
时间窗: 9 months
in-stent late lumen loss (LLL), defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD.
次要结局
- Composite endpoint of (all cause) mortality, Myocardial Infarction (Q-wave and non Q-wave) or (any) revascularization(30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr)
- MACE composite endpoint(30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr)
- Target lesion failure (TLF)(30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr)
- Lesion success(At the end of the index procedure or during hospital stay)
- Target vessel failure (TVF)(30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr)
- Stent thrombosis(30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr)
- Procedure success(At the end of the index procedure or during hospital stay)
- Myocardial infarction(30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr)
- All revascularizations(30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr)
- Device success(at the end of the index procedure or during hospital stay)
- Death(30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr)