Naples PCI Registry

Federico II University

Status: Enrolling

Conditions: Coronary Artery Disease; Myocardial Ischemia; Percutaneous Coronary Intervention; Acute Coronary Syndrome; Myocardial Infarction

Treatments: Device: PCI

Study type: Observational

Funder types: Other

Identifiers

NCT05248165

232/18

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Inability to provide informed consent.

Trial design

5,000 participants in 1 patient group

Coronary artery disease requiring percutaneous coronary intervention

Description:

Chronic or acute coronary syndrome requiring percutaneous myocardial revascularization.

Treatment:

Device: PCI