A MAajor RAdiation-based PCI Study in STEMI and NSTEMI (MARAA)

Centre Cardiologique du Nord

Status: Not yet enrolling

Conditions: Coronary Artery Disease; Coronary Syndrome; Radiation Toxicity; Coronary Thrombosis; Myocardial Infarction (MI); Coronary Artery Calcification; Coronary Occlusion; Coronary Stenosis

Treatments: Device: Complex PCI; Device: Non Complex PCI

Study type: Observational

Funder types: Other

Identifiers

NCT06565793

ID: CN-08-24

Details and patient eligibility

About

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.

Full description

A retrospective database of the hemodynamics department of the Centre Cardiologique du Nord and Clinica Mediterranea, comprising 15,630 consecutive angioplasties performed in unselected patients between February 1, 2008, and July 7, 2018, was used to identify complex angioplasties and standard angioplasties. Two categories of complex angioplasty were identified: complex angioplasty with a single complexity criterion and very complex angioplasty with two or more complexity criteria. These complex angioplasties were then compared with standard angioplasty (angioplasty with no complexity criteria).

The following criteria were employed to delineate complex or very complex angioplasties:

• Unprotected Left Coronary Common Trunk Angioplasty (UT-PCI)
• Angioplasty with Rotablator Rotary Atherectomy (ARota-PCI)
• Angioplasty of Chronic Coronary Occlusion (CCO-PCI)
• Angioplasty of a Bifurcation Lesion (CBL-PCI)

The following definitions pertain to the classification of angioplasty procedures:

• Standard angioplasty: This encompasses angioplasty procedures that do not meet the criteria for complexity.
• Complex angioplasty: This designation is applied to angioplasty procedures that meet at least one criterion for complexity.
• Very complex angioplasty: This designation is applied to angioplasty procedures that meet at least two criteria for complexity.

Enrollment: 15,630 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient presents with a STEMI or NSTEMI requiring either a non-complex or complex PCI.

Exclusion criteria

Trial design

15,630 participants in 2 patient groups

Non Complex PCI

Description:

The objective of this study is to examine the efficacy of percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES) in patients diagnosed with ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction (NSTEMI).

Treatment:

Device: Non Complex PCI

Complex PCI

Description:

This study focuses on patients diagnosed with either STEMI or NSTEMI who have undergone complex percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).The following criteria were used to distinguish between complex and very complex angioplasty cases: The following procedures have been identified as complex or very complex: * Unprotected Left Coronary Common Trunk Angioplasty (UT-PCI) * Angioplasty with Rotablator Rotary Atherectomy (ARota-PCI) * Angioplasty of Chronic Coronary Occlusion (CCO-PCI)

Treatment:

Device: Complex PCI