SUPRAFLEX CRUZ PMCF Study ( rEpic05 )

Fundación EPIC508 enrolled

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).

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.

Study Type

OBSERVATIONAL

Enrollment

508

Conditions

Coronary Artery Disease (CAD)Ischemic Heart Disease

Interventions

SUPRAFLEX CRUZDEVICE

Patients in whom treatment with SUPRAFLEX CRUZ has been attempted

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (21)

Hospital General Universitario de Elche

Elche, Alicante, Spain

Outcomes

Primary Outcomes

Target Lesion Failure (TLF)

Rate of target lesion failure

Time frame: 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

Time frame: 12 months

Secondary Outcomes

Major Adverse Cardiovascular Event (MACE)

Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 1 month

Changes in left ventricular ejection fraction (LVEF)

Central Contacts

Bruno Garcia, MD, PhD

CONTACT

0034932746155 brunogb51@gmail.com

FUNDACION EPIC

CONTACT

0034987225638 iepic@fundacionepic.org

Data from ClinicalTrials.gov

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