SUPRAFLEX CRUZ PMCF Study ( rEpic05 )
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación EPIC
About this trial
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
Qualifiers
≥ 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
Disqualifiers
Not meet inclusion criteria
Contraindication for antiplatelet treatment
Patient life expectancy less than 12 months
Trial design
Treatments tested in this trial
- SUPRAFLEX CRUZ
Treatment groups
508 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov