Naples PCI Registry

Sponsor

Federico II University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05248165

Collaborator

(none)

5,000

Enrollment

Location

121

Anticipated Duration (Months)

41.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Percutaneous Coronary Intervention Myocardial Ischemia Myocardial Infarction Acute Coronary Syndrome	Device: PCI

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Naples PCI Registry

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Mar 30, 2032

Anticipated Study Completion Date :

Mar 30, 2032

Arms and Interventions

Arm	Intervention/Treatment
Coronary artery disease requiring percutaneous coronary intervention Chronic or acute coronary syndrome requiring percutaneous myocardial revascularization.	Device: PCI Percutaneous coronary intervention

Arm

Intervention/Treatment

Coronary artery disease requiring percutaneous coronary intervention

Chronic or acute coronary syndrome requiring percutaneous myocardial revascularization.

Device: PCI

Percutaneous coronary intervention

Outcome Measures

Primary Outcome Measures

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 target-vessel revascularization [12 months]
Target vessel revascularization
Number of patients with target-lesion revascularization [12 months]
Target lesion revascularization
Number of patients with contrast-induced acute kidney injury [12 months]
Contrast-induced acute kidney injury
Number of patients with bleeding [12 months]
Bleeding