SUPRAFLEX CRUZ PMCF Study ( rEpic05 ) (Multiflex)

Fundación EPIC

Status

Enrolling

Conditions

Ischemic Heart Disease

Coronary Artery Disease (CAD)

Treatments

Device: SUPRAFLEX CRUZ

Study type

Observational

Funder types

Other

Identifiers

NCT05617599

rEpic05 - Multiflex

Details and patient eligibility

About

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).

Full 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.

Enrollment

508 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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