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Recruiting NCT05617599

NCT05617599 SUPRAFLEX CRUZ PMCF Study ( rEpic05 )

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Clinical Trial Summary
NCT ID NCT05617599
Status Recruiting
Phase
Sponsor Fundación EPIC
Condition Coronary Artery Disease (CAD)
Study Type OBSERVATIONAL
Enrollment 508 participants
Start Date 2023-05-10
Primary Completion 2026-12-01

Trial Parameters

Condition Coronary Artery Disease (CAD)
Sponsor Fundación EPIC
Study Type OBSERVATIONAL
Phase N/A
Enrollment 508
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-05-10
Completion 2026-12-01
Interventions
SUPRAFLEX CRUZ

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Brief 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 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

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