SUPRAFLEX CRUZ PMCF Study ( rEpic05 )

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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SUPRAFLEX CRUZPost-Market Clinical Follow-up Study

Conditions
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Coronary Artery Disease (CAD), Ischemic Heart Disease

Intervention / Treatment
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* Device: SUPRAFLEX CRUZ


Participation Criteria
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Eligibility Criteria
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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 Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary Artery Disease (CAD)<br> | Device: SUPRAFLEX CRUZ<br>* Patients in whom treatment with SUPRAFLEX CRUZ has been attempted<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF) | Rate of target lesion failure | 12 months | 
| Device-oriented Composite Endpoint (DoCE) | Device-oriented Composite Endpoint (DoCE) defined as the composite of: Cardiovascular death, target vessel myocardial infarction, clinically indicated repeat revascularization of the target lesion at 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Event (MACE) | Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke | 12 months | 
| Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography | In the subgroup of patients with reduced Ejection Fraction, Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography | 1 month | 
| Change from baseline in Global Longitudinal Strain measured by strain-rate echocardiography | In the subgroup of patients with reduced Ejection Fraction, Change from baseline in Global Longitudinal Strain measured by strain-rate echocardiography | 1 month | 
| Change of segmental movement of the territory revascularized measured by echocardiography | In the subgroup of patients with reduced Ejection Fraction, Change from baseline segmental movement of the territory revascularized measured by echocardiography | 1 month | 
| Changes in left ventricular ejection fraction (LVEF) | Changes in left ventricular ejection fraction (LVEF) from baseline and from 1 month post-procedure/pre-hospital discharge as assessed by echo in the subgroup of ventricular dysfunction | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CE-MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up)