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NCT Number: NCT05248165

Naples PCI Registry

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.

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Key information

Conditions

Coronary Artery Disease Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Percutaneous Coronary Intervention Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Advanced Biomedical Sciences

Naples, 80131, Italy

Location status: Recruiting

Location contact

Raffaele Piccolo, MD,PhD

CONTACT

[email protected]

+390817464325

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Inability to provide informed consent.

Treatment and study plan

PCI

Device

Percutaneous coronary intervention

Primary outcomes

  1. Number of patients with death

    Time frame: 12 months

    Death

  2. Number of patients with myocardial infarction

    Time frame: 12 months

    Myocardial infarction

  3. Number of patients with stroke

    Time frame: 12 months

    Stroke

  4. Number of patients with stent thrombosis

    Time frame: 12 months

    Stent thrombosis

  5. Number of patients with target-vessel revascularization

    Time frame: 12 months

    Target vessel revascularization

  6. Number of patients with target-lesion revascularization

    Time frame: 12 months

    Target lesion revascularization

  7. Number of patients with contrast-induced acute kidney injury

    Time frame: 12 months

    Contrast-induced acute kidney injury

  8. Number of patients with bleeding

    Time frame: 12 months

    Bleeding

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Esposito, MD, PhD

CONTACT

[email protected]

+390817463075

Raffaele Piccolo, MD, PhD

CONTACT

[email protected]

+390817464325

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Feb 21, 2022
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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