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NOT YET RECRUITING
NCT06565793

A MAajor RAdiation-based PCI Study in STEMI and NSTEMI

Sponsor: Centre Cardiologique du Nord

View on ClinicalTrials.gov

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.

Official title: The Impact of Radiation Delivered to the Patient and the Amount of Iodinated Contrast Medium Injected in Complex Versus Noncomplex Percutaneous Coronary Intervention.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

15630

Start Date

2025-03-01

Completion Date

2025-12-31

Last Updated

2024-12-27

Healthy Volunteers

No

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.