AzTrials
AzTrials

Coronary Artery DiseaseNCT05248165

Naples PCI Registry

An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Federico II University at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PCI
Type of treatment
Medical device
How many people
5,000 participants
Where
1 siteItaly
Study dates
1 Mar 2022to 30 Mar 2032
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with coronary artery disease undergoing PCI at University of Naples "Federico II".

Who may be able to join

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

Who cannot join

  • 1. Inability to provide informed consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Giovanni Esposito, MD, PhD contact

+390817463075

espogiov@unina.it

Raffaele Piccolo, MD, PhD contact

+390817464325

rafffaele.piccolo@unina.it

Italy1 site, 1 recruiting

  • Department of Advanced Biomedical Sciences

    Naples, 80131

    Raffaele Piccolo, MD,PhD, +390817464325, rafffaele.piccolo@unina.it

    Recruiting

Other trials in Italy

About this study

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.

Read the 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).

Being tested
PCI
Keywords
Percutaneous coronary intervention, Coronary artery disease
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCIDevice

    Percutaneous coronary intervention

Study groups in NCT05248165
Study groupRoleWhat they receive
Coronary artery disease requiring percutaneous coronary interventionChronic or acute coronary syndrome requiring percutaneous myocardial revascularization.
Receives: Device: PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with death

    Death

    Measured: 12 months

  2. Number of patients with myocardial infarction

    Myocardial infarction

    Measured: 12 months

  3. Number of patients with stroke

    Stroke

    Measured: 12 months

  4. Number of patients with stent thrombosis

    Stent thrombosis

    Measured: 12 months

  5. Number of patients with target-vessel revascularization

    Target vessel revascularization

    Measured: 12 months

  6. Number of patients with target-lesion revascularization

    Target lesion revascularization

    Measured: 12 months

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

    Contrast-induced acute kidney injury

    Measured: 12 months

  8. Number of patients with bleeding

    Bleeding

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2022
  2. Study start1 Mar 2022
  3. Primary completion30 Mar 2032 (estimated)
  4. Study completion30 Mar 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT05248165
Sponsor's protocol ID
232/18
Status last verified
Feb 2024
First submitted
10 Feb 2022
Last updated
23 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Piccolo R, Giustino G, Mehran R, Windecker S. Stable coronary artery disease: revascularisation and invasive strategies. Lancet. 2015 Aug 15;386(9994):702-13. doi: 10.1016/S0140-6736(15)61220-X.

    PubMed 26334162

  • Byrne RA, Stone GW, Ormiston J, Kastrati A. Coronary balloon angioplasty, stents, and scaffolds. Lancet. 2017 Aug 19;390(10096):781-792. doi: 10.1016/S0140-6736(17)31927-X.

    PubMed 28831994

  • Cuisset T, Verheugt FWA, Mauri L. Update on antithrombotic therapy after percutaneous coronary revascularisation. Lancet. 2017 Aug 19;390(10096):810-820. doi: 10.1016/S0140-6736(17)31936-0.

    PubMed 28831996

  • Rothwell PM. External validity of randomised controlled trials: "to whom do the results of this trial apply?". Lancet. 2005 Jan 1-7;365(9453):82-93. doi: 10.1016/S0140-6736(04)17670-8.

    PubMed 15639683

  • King M, Nazareth I, Lampe F, Bower P, Chandler M, Morou M, Sibbald B, Lai R. Impact of participant and physician intervention preferences on randomized trials: a systematic review. JAMA. 2005 Mar 2;293(9):1089-99. doi: 10.1001/jama.293.9.1089.

    PubMed 15741531

  • Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.

    PubMed 29891620

  • Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available.

    PubMed 22922414

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Federico II University at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giovanni Esposito, MD, PhD (+390817463075, espogiov@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with death (time frame: 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05248165, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.

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