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NCT Number: NCT05617599

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).

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Key information

Conditions

Coronary Artery Disease (CAD) Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Ischemic Heart Disease Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Universitario de Elche, Elche, Alicante, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SUPRAFLEX CRUZ

Device

Patients in whom treatment with SUPRAFLEX CRUZ has been attempted

Primary outcomes

  1. Target Lesion Failure (TLF)

    Time frame: 12 months

    Rate of target lesion failure

  2. Device-oriented Composite Endpoint (DoCE)

    Time frame: 12 months

    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

Secondary outcomes

  1. Major Adverse Cardiovascular Event (MACE)

    Time frame: 12 months

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

  2. Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography

    Time frame: 1 month

    In the subgroup of patients with reduced Ejection Fraction, Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography

  3. Change from baseline in Global Longitudinal Strain measured by strain-rate echocardiography

    Time frame: 1 month

    In the subgroup of patients with reduced Ejection Fraction, Change from baseline in Global Longitudinal Strain measured by strain-rate echocardiography

  4. Change of segmental movement of the territory revascularized measured by echocardiography

    Time frame: 1 month

    In the subgroup of patients with reduced Ejection Fraction, Change from baseline segmental movement of the territory revascularized measured by echocardiography

  5. Changes in left ventricular ejection fraction (LVEF)

    Time frame: 1 month

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Bruno Garcia, MD, PhD

CONTACT

[email protected]

0034932746155

FUNDACION EPIC

CONTACT

[email protected]

0034987225638

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Official study title

SUPRAFLEX CRUZPost-Market Clinical Follow-up Study

Acronym: Multiflex

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 15, 2022
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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