SUPRAFLEX CRUZ PMCF Study ( rEpic05 )
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).
| Condition(s) | Coronary Artery Disease (CAD), Ischemic Heart Disease |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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). |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fundación EPIC |
| Locations | Elche, Alicante, Spain; A Coruña, Spain; Barakaldo, Spain; Barcelona, Spain; Barcelona, Spain; Castelló, Spain (+15 more sites) |
| Start date | 2023-05-10 |
| NCT ID | NCT05617599 |
| Official listing | https://clinicaltrials.gov/study/NCT05617599 |