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SUPRAFLEX CRUZ PMCF Study ( rEpic05 )
RECRUITINGSponsored by Fundación EPIC
Actively Recruiting
SponsorFundación EPIC
Started2023-05-10
Est. completion2026-12-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05617599
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
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * ≥ 18 years old and; * Patients treated with SUPRAFLEX CRUZ according to routine hospital practice and following instructions for use * Patients 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 Echocardiography * Informed consent signed Exclusion Criteria: * Not meet inclusion criteria * Contraindication for antiplatelet treatment * Patient life expectancy less than 12 months
Conditions3
Coronary Artery Disease (CAD)Heart DiseaseIschemic Heart Disease
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
SponsorFundación EPIC
Started2023-05-10
Est. completion2026-12-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05617599