NCT01967199终止4 期
Treatment of Drug-Eluting Stent REstenosis Using Drug-Eluting STents vs. Drug-COated Balloon for Preventing REcurrent In-Stent Restenosis
Seung-Jung Park11 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2013年4月18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
- 175
- 试验地点
- 11
- 主要终点
- Late luminal loss
研究概览
简要总结
The purpose of this study is to establish the safety and effectiveness of paclitaxel eluting balloon (SeQuent Please) compared to coronary stenting with the Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) in the treatment of drug eluting stent restenosis.
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
- •The patient must be more than or equal to 20 years of age
- •Restenosis after drug-eluting stents (>50% by visual estimate)
- •Any Lesion length including focal in stent restenosis or diffuse in stent restenosis
- •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) Everolimus 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
- •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
研究组 & 干预措施
Drug Eluting Stent
Active Comparator
Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)
干预措施: Everolimus-eluting balloon expandable stent (Device)
paclitaxel eluting balloon
Experimental
paclitaxel eluting balloon (SeQuent Please)
干预措施: paclitaxel eluting balloon (Device)
结局指标
主要结局
Late luminal loss
时间窗: 9months
Late luminal loss at 9 months angiographic follow-up.
次要结局
- Death(1 year)
- In-segment or in-stent restenosis at 9 month angiographic follow-up(1 year)
- Target lesion revascularization(1 year)
- Target vessel revascularization(1 year)
- Stent thrombosis(1 year)
- Myocardial infarction(1 year)
- Procedural success(3day)
研究者
Seung-Jung Park
M.D, Ph.D.
Asan Medical Center
研究点 (11)
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