Naples PCI Registry

Recruiting

• Conditions: Coronary Artery Disease; Myocardial Ischemia; Percutaneous Coronary Intervention; Acute Coronary Syndrome; Myocardial Infarction
• Interventions: Device: PCI

• Registration Number: NCT05248165
• Lead Sponsor: Federico II University

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-21
• Study Start: 2022-03-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Primary Completion: 2032-03-30
• Study Completion: 2032-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary artery disease requiring percutaneous coronary intervention	PCI	Chronic or acute coronary syndrome requiring percutaneous myocardial revascularization.

Primary Outcome Measures

Name	Time	Method
Number of patients with target-lesion revascularization	12 months	Target lesion revascularization
Number of patients with death	12 months	Death
Number of patients with myocardial infarction	12 months	Myocardial infarction
Number of patients with stroke	12 months	Stroke
Number of patients with stent thrombosis	12 months	Stent thrombosis
Number of patients with contrast-induced acute kidney injury	12 months	Contrast-induced acute kidney injury
Number of patients with bleeding	12 months	Bleeding
Number of patients with target-vessel revascularization	12 months	Target vessel revascularization

Trial Locations

Locations (1)

Department of Advanced Biomedical Sciences; 🇮🇹 Naples, Italy