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临床试验/NCT03673254
NCT03673254已完成不适用

A Prospective Multinational European Study on Evaluation of Practices and Prognostic Factors of Percutaneous Coronary Interventions (PCI) of Calcified Complex Lesions Using Rotational Atherectomy Device.

University Hospital, Toulouse15 个研究点 分布在 7 个国家目标入组 1,026 人开始时间: 2016年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,026
试验地点
15
主要终点
Determination of the prognostic impact of a myocardial

研究概览

简要总结

In spite of technological advances, PCI of complex calcified coronary lesions remain a challenge.

Observational studies demonstrate that moderate or severe calcifications in lesions to treat are associated with an increase in mortality, in myocardial infarctions, in stent thrombosis, and in complementary revascularizations. Rotational atherectomy is now part of therapeutic armamentarium of interventional cardiologists for the treatment of some complex calcified coronary lesions. Last recommendations of the European Society of Cardiology about revascularizations indicate that rotational atherectomy should be used for "the preparation of calcified or massive fibrotic lesions that cannot be crossed by a balloon or for an optimal dilatation before stenting". However, this technique is not frequently used and limited to high-volume PCI centers. Even though rotational atherectomy demonstrated an improvement in immediate success of complex lesions, the longterm reduction of cardiovascular events after active stenting has not been proved. In observational studies, the results are not consistent because of many selection biases that influence the choice of an angioplasty with rotational atherectomy device (calcifications, severity of the disease). Furthermore, this technique needs operators with a certain amount of experience. The fundamentals of an optimal use of rotational atherectomy remain to be defined (duration and speed of burr, anti-platelet treatments...).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with angioplasty that requires the rotational atherectomy device
  • agree to participate in this study

排除标准

  • 未提供

结局指标

主要结局

Determination of the prognostic impact of a myocardial

时间窗: One year

Composite safety endpoint collecting cardiovascular events (cardiovascular death, myocardial infarction, target lesion revascularization, stroke, stent thrombosis, coronary bypass)

次要结局

  • Frequency of angiographic complications for an optimization of PCI by rotational atherectomy(one year)
  • Frequency of in-hospital events(One year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (15)

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