NCT01489761终止4 期
Percutaneous Treatment of Very LONG Native Coronary Lesions With Drug-Eluting Stent-VI: Everolimus-eluting Versus Zotarolimus-Eluting Stents
Seung-Jung Park11 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2012年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 302
- 试验地点
- 11
- 主要终点
- In-segment late luminal loss at 13 month follow-up
研究概览
简要总结
This is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) for very long coronary lesions.
详细描述
Following angiography, patients with significant diameter stenosis > 50% and lesion length (> 50mm) requiring at least 2 multiple long-stent placement by visual estimation and eligible for LONG-DES VI trial inclusion and exclusion criteria will be randomized 1:1 to zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) by the stratified randomization method.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 20 years
- •Significant native coronary artery stenosis (> 50% by visual estimate) with lesion length of more than 50mm, which requires at least 2 multiple long stent placement without intervening normal segment
- •Patients with silent ischemia, stable or unstable angina pectoris, and Non-ST-elevation myocardial infarction (NSTEMI)
- •The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site
排除标准
- •Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, zotarolimus, or everolimus
- •An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment
- •Acute ST-segment-elevation MI or cardiogenic shock
- •Terminal illness with life expectancy < 1 year
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
- •In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment) However, non-target vessel In-stent restenosis is permitted
- •Patients with EF < 30%
- •Serum creatinine level >=2.0mg/dL or dependence on dialysis
- •Patients with left main stem stenosis (> 50% visual estimate)
研究组 & 干预措施
zotarolimus-eluting stent
Active Comparator
Resolute Integrity or Resolute Onyx stent
干预措施: percutaneous coronary intervention (Device)
everolimus-eluting stent
Experimental
Xience Prime or Xience Xpedition or Xience Alpine stent
干预措施: percutaneous coronary intervention (Device)
结局指标
主要结局
In-segment late luminal loss at 13 month follow-up
时间窗: 13 month post stenting
次要结局
- 1. All Death(12 month clinical follow-up)
- 6. Target vessel revascularization (ischemia-driven and clinically-driven)(12 month clinical follow-up)
- 10. In-stent late loss(13 month angiographic follow-up)
- 7. Target lesion revascularization (ischemia-driven and clinically-driven)(12 month clinical follow-up)
- 8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)(12 month clinical follow-up)
- 9. Stent thrombosis (ARC criteria)(12 month clinical follow-up)
- 11. In-stent and in-segment restenosis(13 month angiographic follow-up)
- 12. Angiographic pattern of restenosis(13 month angiographic follow-up)
- 14. Incidence of late stent malapposition(13 month IVUS follow-up)
- 15. Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay(2-3 days post stenting)
- 13. Volume of intimal hyperplasia(13 month IVUS follow-up)
- 2. Cardiac death(12 month clinical follow-up)
- 3. Myocardial infarction (MI)(12 month clinical follow-up)
- 4. Composite of death or MI(12 month clinical follow-up)
- 5. Composite of cardiac death or MI(12 month clinical follow-up)
研究者
Seung-Jung Park
MD,PhD
CardioVascular Research Foundation, Korea
研究点 (11)
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