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临床试验/NCT05248165
NCT05248165招募中不适用

Naples PCI Registry

Federico II University1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
5,000
试验地点
1
主要终点
Number of patients with target-lesion revascularization

研究概览

简要总结

The aim of the Naples PCI registry is to collect prospective data on baseline clinical, laboratory, and angiographic characteristics of patients undergoing PCI for acute or chronic coronary artery disease. All patients receive clinical follow-up at hospital discharge and at 1-year follow-up with the objective to assess clinical outcomes, including death, cardiovascular death, myocardial infarction, stroke, stent thrombosis, target-lesion and target-vessel revascularization, contrast-induced acute kidney injury, and bleeding events.

详细描述

Percutaneous coronary intervention (PCI) constitutes the most commonly performed therapeutic procedure in cardiovascular medicine and one on the most frequent interventions performed in medicine. Since the introduction of the procedure more than 40 years ago, the safety and efficacy profile of PCI has steadily improved with continuous advances in the technique, equipment, and procedural success. In the late 1980s, the advent of coronary stents favored the widespread adoption of PCI in routine clinical practice by eliminating the risk of periprocedural abrupt closure related to coronary dissection and, as corollary, the need for standby emergent coronary artery bypass grafting. Nowadays, about three out of four patients requiring myocardial revascularization are managed PCI.

The objective of this study is to evaluate, within the framework of a prospective registry, the safety and efficacy of PCI by considering all device iterations including stent-based as well as non-stent-based interventions. We will evaluate clinical, laboratory, angiographic data of all patients undergoing PCI at the Federico II University Hospital. Clinical follow-up is collected during hospital stay and at 1-year after PCI. All adverse events are independently adjudicated by a clinical events committee (CEC).

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

  • Clinical evidence of coronary artery disease requiring PCI;
  • Age ≥18 years;
  • Written informed consent.

排除标准

  • Inability to provide informed consent.

结局指标

主要结局

Number of patients with target-lesion revascularization

时间窗: 12 months

Target lesion revascularization

Number of patients with death

时间窗: 12 months

Death

Number of patients with myocardial infarction

时间窗: 12 months

Myocardial infarction

Number of patients with stroke

时间窗: 12 months

Stroke

Number of patients with stent thrombosis

时间窗: 12 months

Stent thrombosis

Number of patients with contrast-induced acute kidney injury

时间窗: 12 months

Contrast-induced acute kidney injury

Number of patients with bleeding

时间窗: 12 months

Bleeding

Number of patients with target-vessel revascularization

时间窗: 12 months

Target vessel revascularization

次要结局

未报告次要终点

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Esposito

MD, PhD

Federico II University

研究点 (1)

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