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A MAajor RAdiation-based PCI Study in STEMI and NSTEMI

NCT06565793 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 15630

Last updated 2024-12-27

No results posted yet for this study

Summary

In France and Italy, approximately 240,000 percutaneous coronary angioplasties (PCI) are performed annually, with an increasing number of complex procedures, including those involving the left coronary common trunk, a bifurcation, chronic occlusion, or requiring Rotablator Rotary Atherectomy (ARota). The medical literature lacks sufficient data regarding several key aspects of complex angioplasty. These include the epidemiological characteristics of patients undergoing such procedures, the impact of irradiation delivered and the quantity of iodine injected on these lengthy procedures, their procedural complication rate, and in-hospital mortality.

Conditions

  • Myocardial Infarction (MI)
  • Radiation Toxicity
  • Coronary Stenosis
  • Coronary Thrombosis
  • Coronary Artery Calcification
  • Coronary Occlusion
  • Coronary Syndrome
  • Coronary Artery Disease

Interventions

DEVICE

Non Complex PCI

The patient cohort included individuals who had been hospitalized with a diagnosis of either STEMI or non-STEMI. The procedure involved percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).

DEVICE

Complex PCI

The patient cohort included individuals who had been hospitalized with a diagnosis of either STEMI or non-STEMI. The procedure involved complex percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).This designation is applied to angioplasty procedures that meet at least one criterion for complexity. The complex angioplasty involved patients with unprotected left coronary common trunk (UT-PCI), the use of rotablator rotary atherectomy (ARota-PCI), the angioplasty of chronic coronary occlusion (CCO-PCI), or the angioplasty of a bifurcation lesion (CBL-PCI).The highly intricate angioplasty procedure was conducted on patients who met at least two criteria indicative of complexity.

Sponsors & Collaborators

  • Clinica Mediterranea

    collaborator OTHER

  • Centre Cardiologique du Nord

    lead OTHER

Principal Investigators

  • Francesco Nappi, MD · Centre Cardiologique du Nord

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-07-01
Completion
2025-12-31
FDA Device
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06565793 on ClinicalTrials.gov