A MAajor RAdiation-based PCI Study in STEMI and NSTEMI
NCT Number: NCT06565793
Acronym: MARAA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
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|DEVICE: Complex PCI
Sponsor: Centre Cardiologique du Nord
Collaborators: Clinica Mediterranea
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15630
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2025-12-31

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.

Primary Outcome Measures: 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: 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