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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Coronary Occlusion; Coronary Stenosis; Radiation Toxicity; Coronary Thrombosis; Coronary Artery Calcification; Coronary Syndrome; Myocardial Infarction (MI)
• Intervention / Treatment: Device: Non Complex PCI; Device: Complex PCI

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 15630

Contacts and Locations

• Study Contact: Name: Francesco Nappi, MD; Phone Number: +33 782298823; Email: francesconappi2@gmail.com
• Study Contact Backup: Name: Francesco Nappi, MD; Phone Number: +33 49334119; Email: francesconappi2@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non Complex PCI; 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).	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).
Complex PCI; 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)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	The primary end point of the study is the rate of death	30 days
Death	The primary end point of the study is the rate of death	1 year
Death	The primary end point of the study is the rate of death	5 years
Myocardial Infarction	The primary end point of the study is the rate of myocardial infarction	30 days
Myocardial Infarction	The primary end point of the study is the rate of myocardial infarction	1 year
Myocardial Infarction	The primary end point of the study is the rate of myocardial infarction	5 years
Stent Thrombosis	The primary end point of the study is the rate of stent thrombosis	30 days
Stent Thrombosis	The primary end point of the study is the rate of stent thrombosis	1 year
Stent Thrombosis	The primary end point of the study is the rate of stent thrombosis	5 years
Acute Kidney Injury	The primary end point of the study is the rate of acute kidney injury	30 days
Acute Kidney Injury	The primary end point of the study is the rate of acute kidney injury	1 years
Coronary Obstruction Requiring Intervention	The primary end point of the study is the rate of coronary obstruction requiring intervention	30 days
Coronary Obstruction Requiring Intervention	The primary end point of the study is the rate of coronary obstruction requiring intervention	1 year
Coronary Obstruction Requiring Intervention	The primary end point of the study is the rate of coronary obstruction requiring intervention	5 years
Increase in Tnl and Tnt Levels	The primary end point of the study is the rate in increase of Tnl and Tnt levels	30 days
Increase in Tnl and Tnt Levels	The primary end point of the study is the rate in increase of Tnl and Tnt levels	1 year
Rehospitalization	The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)	30 days
Rehospitalization	The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)	1 year
Rehospitalization	The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Vessel Revascularization	The secondary end point of the study is the rate of target vessel revascularization	1 year
Target Vessel Revascularization	The secondary end point of the study is the rate of target vessel revascularization	5 years
Target Lesion Revascularization	The secondary end point of the study is the rate of target lesion revascularization	1 year
Target Lesion Revascularization	The secondary end point of the study is the rate of target lesion revascularization	5 years

Collaborators and Investigators

• Sponsor: Centre Cardiologique du Nord
• Collaborators: Clinica Mediterranea
• Investigators: Principal Investigator: Francesco Nappi, MD, Centre Cardiologique du Nord

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 11, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: PCI,DES, Radiation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Embolism and Thrombosis; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Ischemia; Thrombosis; Coronary Artery Disease; Coronary Stenosis; Myocardial Infarction; Infarction; Coronary Thrombosis; Coronary Occlusion
• Other Study ID Numbers: ID: CN-08-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes