RecruitingNCT05617599
SUPRAFLEX CRUZ PMCF Study ( rEpic05 )
SUPRAFLEX CRUZPost-Market Clinical Follow-up Study
Sponsor
Fundación EPIC
Enrollment
508 participants
Start Date
May 10, 2023
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria7
- ≥ 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
- Contraindication for antiplatelet treatment
- Patient life expectancy less than 12 months
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Interventions
DEVICESUPRAFLEX CRUZ
Patients in whom treatment with SUPRAFLEX CRUZ has been attempted
Locations(21)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05617599
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