Prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of net adverse clinical outcomes (NACE) of transfemoral vs. transradial approach for the treatment of patients with ST-elevation acute coronary syndrome (STEACS) undergoing primary angioplasty
Prospective, randomized, double arm study. The study population will include all consecutive patients presenting with a ST-elevation Acute Coronary Syndrome and candidates for primary percutaneous coronary intervention, who agree and provide written informed consent for the study. Before arterial stick for percutaneous access, patients will be randomized according to sealed numbered envelopes. Subsequently, arterial access will be obtained and the diagnostic/interventional procedure will be performed according to routine clinical practice, leaving ancillary medications, choice of devices and means of hemostasis at the physician's discretion. In the randomization process all participating centers will be equally stratified to avoid statistical unbalance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,001
diagnostic and interventional procedures by femoral artery access
diagnostic and interventional procedures by radial artery access
Università di Modena e Reggio Emilia
Modena, Modena, Italy
Ospedale Sandro Pertini
Rome, Rome, Italy
Policlinico Casilino
Rome, Rome, Italy
University of Turin, San Giovanni Battista Hospital
Turin, Turin, Italy
Net Adverse Clinical Event
Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding
Time frame: 30-day
Net Adverse Clinical Event
Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding
Time frame: 1-year
Individual components of NACE
Cardiac death, Myocardial infarction, Target Lesion revascularization, Stroke, Major Bleeding
Time frame: 30-day
Individual components of NACE
Cardiac death, Myocardial infarction, Target Lesion revascularization, Stroke, Major Bleeding
Time frame: 1-year
Total procedural and fluoroscopy times for the index procedure
Comparison of procedural and fluoroscopy times between the two study groups
Time frame: 1 day
Hospital stay
Days of hospitalization
Time frame: 30-day
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