跳至主要内容
临床试验/NCT05787886
NCT05787886进行中(未招募)不适用

Clinical Outcomes of Percutaneous Coronary Intervention With Rotational Atherectomy: the Poland Single RA-BIA Registry

Medical University of Bialystok1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2007年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,200
试验地点
1
主要终点
Rate of various endpoints

研究概览

简要总结

The RA-BIA Registry is a single-center observational study. The study included consecutive patients from 2008 who met inclusion criteria and were treated with RA. The main aim of the study is to assess the efficacy of rotational atherectomy.

详细描述

Severe coronary artery calcifications occur in about 10% of patients undergoing percutaneous coronary intervention (PCI). They constitute a strong independent predictor of an adverse cardiovascular event. Even though the risk factors and pathomechanisms leading to severe coronary calcification are well understood, the options for effective treatment remain insufficient.

In the presence of severe calcification, standard PCI has inferior immediate and long-term outcomes. In this situation, advanced lesion modification techniques are indispensable to improve PCI outcomes. Dedicated balloons and essentially ablative techniques are available. Rotational atherectomy (RA) is the oldest and best-recognized ablative technique. It is generally acknowledged that superficial modification of calcified atherosclerotic lesions is an optimal mechanism of action in RA.

The RA-BIA Registry is a single-center observational study. The study included consecutive patients from 2008 who met inclusion criteria and were treated with RA. The main aim of the study is to assess the efficacy of rotational atherectomy.

The primary endpoints were device-oriented composite endpoint (DOCE) (defined as a composite of cardiac death, TLR, and target vessel MI), TVR, MI, and cardiac death. TVR and TLR were defined according to the definitions of endpoints for clinical trials. The secondary endpoints were the clinical success rate of the RA procedure (defined as successful revascularization of all treated lesions and the incidence of in-hospital complications including coronary perforation, coronary dissection, coronary low flow or no flow, emergency CABG, tamponade, MI, stroke or transient ischemic attack (TIA), bleeding events (according to the Bleeding Academic Research Consortium [BARC] classification and death.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

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

  • Patient ≥ 18 years old
  • Lesions in target vessels requiring RA
  • Patient accepting the appropriate follow-up as per study definition

排除标准

  • Patient age < 18 years
  • Patients who previously participated in this study.
  • Pregnant and/or breastfeeding females or females who intend to become pregnant.
  • Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) .
  • The subject has an allergy to imaging contrast media which cannot be adequately pre-medicated.

结局指标

主要结局

Rate of various endpoints

时间窗: 5 years

1. Rate of the device-oriented composite end point (DOCE) defined as a composite of cardiac death, target Lesion Revascularization (TLR), and target vessel MI), Target Vessel Revascularization (TVR), myocardial infraction (MI), and cardiac death.

次要结局

  • Procedural, Technical and Clinical Success(5 years)

研究者

发起方
Medical University of Bialystok
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lukasz Kuzma

Assistant Professor

Medical University of Bialystok

研究点 (1)

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