SUPRAFLEX CRUZ PMCF Study ( rEpic05 )

NCT05617599 · tracked via the Priya Life Science Spain tracker

Sponsor

Fundación EPIC

Phase

Observational

Started

2023-05-10

Last updated

2025-12-16

Condition(s) studied

Coronary Artery Disease (CAD)Ischemic Heart Disease

Investigational drug(s) / intervention(s)

SUPRAFLEX CRUZ

SUPRAFLEX CRUZ: Patients in whom treatment with SUPRAFLEX CRUZ has been attempted

Study summary

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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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: * Not meet inclusion criteria * Contraindication for antiplatelet treatment * Patient life expectancy less than 12 months

Primary outcome measure(s)

Target Lesion Failure (TLF) — 12 months
Rate of target lesion failure
Device-oriented Composite Endpoint (DoCE) — 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

Trial sites (21)

Facility	City	Region	Status
Hospital General Universitario de Elche	Elche	Alicante	Recruiting
Hospital Universitario A Coruña	A Coruña	Spain	Recruiting
Hospital Universitario de Cruces	Barakaldo	Spain	Recruiting
Hospital Universitari Vall D'Hebron	Barcelona	Spain	Recruiting
Hospital de La Santa Creu I Sant Pau	Barcelona	Spain	Recruiting
Hospital General Universitario de Castellón	Castelló	Spain	Recruiting
Hospital Universitario San Pedro de Alcántara	Cáceres	Spain	Recruiting
Hospital General Universitario de Ciudad Real	Ciudad Real	Spain	Recruiting
Hospital Universitari Dr. Josep Trueta	Girona	Spain	Recruiting
Hospital Universitario Clínico San Cecilio	Granada	Spain	Recruiting
Hospital Universitario de Leon	León	Spain	Recruiting
Hospital Universitari Arnau de Vilanova	Lleida	Spain	Recruiting
Hospital Universitario 12 de Octubre	Madrid	Spain	Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca	Murcia	Spain	Recruiting
Hospital Parc Tauli	Sabadell	Spain	Recruiting
Hospital Clinico Universitario de Salamanca	Salamanca	Spain	Recruiting
Hospital Clínico Universitario de Santiago de Compostela	Santiago de Compostela	Spain	Recruiting
Hospital Universitario Virgen Del Rocio	Seville	Spain	Recruiting
Hospital Universitario de Toledo	Toledo	Spain	Recruiting
Hospital Universitario Y Politécnico La Fé	Valencia	Spain	Recruiting
Hospital Universitario Lozano Blesa	Zaragoza	Spain	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05617599 on ClinicalTrials.gov ↗ ← All trials in Spain