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Not Yet Recruiting
NCT05617599
SUPRAFLEX CRUZ PMCF Study ( rEpic05 )
Conditions: Coronary Artery Disease (CAD), Ischemic Heart Disease
Sex: All
Ages: 18 Years – N/A
Enrollment: 508
Sponsor: Fundación EPIC
Summary
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Medical Device Regulations (MDR) with multivessel coronary disease requirements in all the CONSECUTIVE patients treated with (SUPRAFLEX CRUZ).
Eligibility Criteria
Inclusion Criteria:≥ 18 years old and;Patients treated with SUPRAFLEX CRUZ according to routine hospital practice and following instructions for usePatients with multivessel coronary artery disease (understood as that which affects more than one territory of the major epicardial coronary arteries - anterior descending, circumflex, right coronary artery) who is treated with more than 1 stent under study in lesions located in more than 1 of the aforementioned arteries.Substudy: Patients with Ejection Fraction <45% by EchocardiographyInformed consent signedExclusion Criteria:Not meet inclusion criteriaContraindication for antiplatelet treatmentPatient life expectancy less than 12 months
Source: ClinicalTrials.gov (NCT05617599). StuddyBuddy aggregates publicly available trial information.