Prospective, Single-blinded, Randomized Comparison of the Clinical and Angiographic Results With Intravascular Analysis of EverolimuS-Eluting Versus ZoTarolimus-Eluting steNTs for In-Stent Restenosis(ISR) Lesions: Volumetric Analysis With Intravascular Ultrasound(IVUS) : Phase IV Multicenter Trial ( RESTENT-ISR Trial )
试验速览
- 阶段
- 4 期
- 入组人数
- 292
- 试验地点
- 2
- 主要终点
- In-stent neointimal volume index
研究概览
简要总结
The purpose of this study is to evaluate the feasibility, safety, and effectiveness of EndeavorTM ResoluteTM and Xience VTM stent implantation in patients with restenosis following drug-eluting stent (DES) implantation. The investigators will evaluate clinical, angiographic and intravascular ultrasound (IVUS) assessment of 9-month efficacy of EndeavorTM ResoluteTM or Xience VTM implantation in DES restenosis and assess the vascular changes of re-treatment with DES for DES restenosis using follow-up IVUS analysis. In addition, the investigators will evaluate the effectiveness of retreatment with EndeavorTM ResoluteTM or Xience VTM stent implantation in patients with restenosis after DES
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In-stent restenosis (over 50% by quantitative angiographic analysis) following all types of DES; only insegment restenotic lesions without ISR are not included
- •Evidence of myocardial ischemia due to restenosis (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the ECG with or without ischemia) or over 70% by quantitative angiographic analysis
- •Repeat revascularization, needed with another stent (single stent implanted lesion, lesion length no more than 28mm )
- •IVUS available lesions
- •Non-emergent conditions
- •Patients confirmed about study enrollment and 9 month followup angiogram and IVUS
排除标准
- •Lesion & Procedural exclusion criteria
- •IVUS unavailable lesion
- •Restenotic lesions following PCI of de novo lesion like as below;
- •left main lesions
- •BMS restenotic lesion
- •vein graft lesion
- •Restenotic lesions following 2.25mm DES implantation
- •Prior history of repeat DES implantation for DES restenosis (only conventional or cutting ballooning treatment for DES restenosis is included in this study)
- •Simultaneous implantation of different types of DES on restenotic or another de novo lesions (Only same DES implantation is allowed on the restenotic or another de novo lesions)
- •Patients with little possibility of performing follow-up angiogram and IVUS
- •General exclusion criteria
- •Contraindication to anti-platelet agents & Bleeding history within prior 3 months
- •Prior history or current presentation of DES thrombosis
- •Age over 80 years
- •Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Zotarolimus, Everolimus
- •Severe hepatic dysfunction (3 times normal reference values)
- •Serum creatinine level over 2.0 mg/dL or end-stage renal diseases on dialysis
- •LVEF less than 30%
- •Pregnant women or women with potential childbearing
- •An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 9 months
- •Life expectancy 1 year
研究组 & 干预措施
Xience V, drug-eluting stent
randomized implantation for DES restenotic lesion
干预措施: Xiene V stent, Endeavor Resolute stent (Device)
Endeavor Resolute, drug-eluting stent
randomized implantation for DES restenotic lesion
干预措施: Xiene V stent, Endeavor Resolute stent (Device)
结局指标
主要结局
In-stent neointimal volume index
时间窗: 9 months on IVUS
次要结局
- Major adverse cardiovascular events(12 months)
- Efficacy end-point(9 months)