NCT00485004已完成4 期
FOcal Type In-stent Restenosis After Drug-Eluting Stent Implantation Treated by CUtting Balloon Angioplasty Versus Sirolimus-Eluting Stent
Seung-Jung Park29 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2007年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 29
- 主要终点
- Binary In-segment Restenosis
研究概览
简要总结
To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent implantation with sirolimus-eluting implantation versus cutting balloon angioplasty
详细描述
Following angiography, patients with focal DES restenosis (lesion length ≤ 10mm) with diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for PCI without any exclusion criteria will be randomized 1:1 to: a) Cypher stent vs. b) Cutting balloon angioplasty. All patients will be followed for 1 year. Angiographic follow-up at 9-months is mandatory.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be at least 18 years of age.
- •Restenosis after drug-eluting stents (>50% by visual estimate)
- •Lesion length < 10 mm (focal ISR)
- •Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention
- •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
- •The patient has a known hypersensitivity or contraindication to any of the following medications:
- •Both Clopidogrel and TIclopidine
- •Sirolimus eluting stent
- •Stainless steel and/or
- •Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
- •Systemic (intravenous) Sirolimus use within 12 months.
- •Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- •History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- •Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- •Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
- •Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- •Patients with EF<30%.
- •Acute MI patients within symptom onset < 12 hours needing primary angioplasty
- •Creatinine level 3.0mg/dL or dependence on dialysis.
- •Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).
- •Patients with left main stem stenosis and left main in-stent restenosis created by DES(>50% by visual estimate)
研究组 & 干预措施
Cutting balloon
Experimental
Cutting balloon
干预措施: Cutting balloon (Device)
Cutting balloon
Experimental
Cutting balloon
干预措施: Sirolimus-eluting stent (Device)
Sirolimus-eluting stent
Active Comparator
Sirolimus-eluting stent
干预措施: Cutting balloon (Device)
Sirolimus-eluting stent
Active Comparator
Sirolimus-eluting stent
干预措施: Sirolimus-eluting stent (Device)
结局指标
主要结局
Binary In-segment Restenosis
时间窗: At 9 months angiographic follow-up
次要结局
- Composite end-point of death, myocardial infarction, or target vessel revascularization(At 9-month after index procedure)
- Stent thrombosis(In-hospital, 30 days, 9 months, and 1year)
- 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)
- Late luminal loss(at 8 month angiographic follow-up)
研究者
Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
CardioVascular Research Foundation, Korea
研究点 (29)
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