Overview
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).
Description
The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the SUPRAFLEX CRUZ in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.
Eligibility
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