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临床试验/NCT03283501
NCT03283501Unknown不适用

A Multicenter Observational Registry on Coronary Revascularization After Implantation of Transcatheter Aortic Valve Bioprosthesis

San Luigi Gonzaga Hospital3 个研究点 分布在 2 个国家目标入组 500 人开始时间: 2017年4月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
3
主要终点
Evaluate the technical feasibility of PCI in patients with prior TAVI

研究概览

简要总结

Evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.

详细描述

The increasing operator experience combined with an improved performance of devices have led to extend current transcatheter aortic valve implantation (TAVI) indications to patients at low or intermediate risk. The safety of TAVI in this population was initially tested in small observational studies and recently reported in the randomized PARTNER 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Trial (SURTAVI) trials, which demonstrated non- inferiority of TAVI in low or intermediate risk patients as compared to surgery with respect to the primary endpoint of death or disabling stroke. In view of the changes in the TAVI population, including younger patients with longer survival, the number of patients that may require coronary revascularization after TAVI is expected to increase over the time. Of note, challenges in performing percutaneous coronary interventions (PCI) in patients previously treated with TAVI have been reported in small series.

Against this background, the purpose of this retrospective multicenter study is to evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.

Objectives

  1. Evaluate the incidence of PCI after TAVI
  2. Evaluate the clinical indications for PCI after TAVI
  3. Evaluate the technical feasibility of PCI in patients with prior TAVI
  4. Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI

研究设计

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

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

  • Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI

排除标准

  • 未提供

结局指标

主要结局

Evaluate the technical feasibility of PCI in patients with prior TAVI

时间窗: intraoperative

Successful target coronary vessel revascularization

Evaluate the incidence of PCI after TAVI

时间窗: up to 5 year after TAVI implantation

Evaluate the incidence of PCI after TAVI

Evaluate the clinical indications for PCI after TAVI

时间窗: intraoperative

Clinical indication for PCI: stable angina; documented silent ischemia; acute coronary syndrome/non-ST elevation myocardial infarction; acute coronary syndrome/ST elevation myocardial infarction

Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI

时间窗: up to 5 year after TAVI implantation

outcome defined as MACE (Major Adverse Coronary Event) a composite of Death, Myocardial Infarction, Target Lesion Failure

次要结局

未报告次要终点

研究者

发起方
San Luigi Gonzaga Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Enrico Cerrato

Principal Investigator

San Luigi Gonzaga Hospital

研究点 (3)

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