Fact CheckerSign in

NCT05617599Recruiting

SUPRAFLEX CRUZ PMCF Study ( rEpic05 )

SUPRAFLEX CRUZPost-Market Clinical Follow-up Study

Source: ClinicalTrials.gov · Last updated 16 Dec 2025

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Observational
Enrollment
508 (estimated)
First submitted
8 Nov 2022
Start date
10 May 2023
Primary completion date
1 Dec 2026
Lead sponsor
Fundación EPIC
NCT number
NCT05617599

What you commit to

  • Study type: Observational
  • Planned participants: 508
  • From 10 May 2023 to the primary completion date, 1 Dec 2026
  • 21 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • ≥ 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitario A Coruña
Coordinator of this site? Confirm its status
A CoruñaSpainRecruiting
Hospital Universitario de Cruces
Coordinator of this site? Confirm its status
BarakaldoSpainRecruiting
Hospital de la Santa Creu i Sant Pau
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario San Pedro de Alcántara
Coordinator of this site? Confirm its status
CáceresSpainRecruiting
Hospital General Universitario de Castellón
Coordinator of this site? Confirm its status
CastellóSpainRecruiting
Hospital General Universitario de Ciudad Real
Coordinator of this site? Confirm its status
Ciudad RealSpainRecruiting
Hospital General Universitario de Elche
Coordinator of this site? Confirm its status
ElcheSpainRecruiting
Hospital Universitari Dr. Josep Trueta
Coordinator of this site? Confirm its status
GironaSpainRecruiting
Hospital Universitario Clínico San Cecilio
Coordinator of this site? Confirm its status
GranadaSpainRecruiting
Hospital Universitario De Leon
Coordinator of this site? Confirm its status
LeónSpainRecruiting
Hospital Universitari Arnau de Vilanova
Coordinator of this site? Confirm its status
LleidaSpainRecruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Coordinator of this site? Confirm its status
MurciaSpainRecruiting
Hospital Parc Tauli
Coordinator of this site? Confirm its status
SabadellSpainRecruiting
Hospital Clinico Universitario de Salamanca
Coordinator of this site? Confirm its status
SalamancaSpainRecruiting
Hospital Clínico Universitario de Santiago de Compostela
Coordinator of this site? Confirm its status
Santiago de CompostelaSpainRecruiting
Hospital Universitario Virgen del Rocio
Coordinator of this site? Confirm its status
SevilleSpainRecruiting
Hospital Universitario de Toledo
Coordinator of this site? Confirm its status
ToledoSpainRecruiting
Hospital Universitario Y Politecnico La Fe
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
Hospital Universitario Lozano Blesa
Coordinator of this site? Confirm its status
ZaragozaSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.