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NCT05752617
European Registry On Plaque ModifiCAtion in the STEMI Population (ROCA-STEMI)
Conditions: Calcified Coronary Lesions, ST Elevated Myocardial Infarction, Plaque Modification Technique
Sex: All
Ages: 18 Years – N/A
Enrollment: 200
Sponsor: Hospital del Mar
Location: Spain
Summary
This is an European prospective cohort study from February 2023 until February 2024.
The investigators want to analyze the clinical success, efficacy and safety of consecutive patients who presented with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) for de novo heavily calcified culprit lesion using plaque modification devices before stent implantation.
Eligibility Criteria
Inclusion Criteria:Age ≥ 18 yearsPatient with a STEMIPrimary percutaneous coronary interventionDe-novo culprit lesion in a native coronary arterySevere calcification of the target lesion or its equivalent (balloon uncrossable or undilatable lesion) (See Definitions 4.4)Mandatory use of a plaque modification device to treat the culprit lesion (See Study device and procedures 4.5)The patient or legal representative signing an informed written consentExclusion Criteria:The target vessel had a stent from a previous PCIThe target lesion was treated as a staged procedurePregnant womenTerminally ill patients
Source: ClinicalTrials.gov (NCT05752617). StuddyBuddy aggregates publicly available trial information.