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Recruiting
NCT05706805
NAVISCORE PMCF Study ( rEPIC04F )
Conditions: Coronary Artery Disease, Ischemic Heart Disease
Sex: All
Ages: 18 Years – N/A
Enrollment: 53
Sponsor: Fundación EPIC
Location: Spain
Summary
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Naviscore scoring balloon to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Naviscore.
Eligibility Criteria
Inclusion Criteria:Patient treated with Naviscore according to routine hospital practice and following instructions for useInformed consent signedExclusion Criteria:• Not meet inclusion criteria
Source: ClinicalTrials.gov (NCT05706805). StuddyBuddy aggregates publicly available trial information.