SUPRAFLEX CRUZ PMCF Study ( rEpic05 )
- Conditions
- Coronary Artery Disease (CAD)Ischemic Heart Disease
- Interventions
- Device: SUPRAFLEX CRUZ
- Registration Number
- NCT05617599
- Lead Sponsor
- Fundación EPIC
- Brief 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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 508
- ≥ 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
- Not meet inclusion criteria
- Contraindication for antiplatelet treatment
- Patient life expectancy less than 12 months
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Coronary Artery Disease (CAD) SUPRAFLEX CRUZ -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Major Adverse Cardiovascular Event (MACE) 12 months Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke
Change from baseline in Global Longitudinal Strain measured by strain-rate echocardiography 1 month In the subgroup of patients with reduced Ejection Fraction, Change from baseline in Global Longitudinal Strain measured by strain-rate echocardiography
Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography 1 month In the subgroup of patients with reduced Ejection Fraction, Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography
Change of segmental movement of the territory revascularized measured by echocardiography 1 month In the subgroup of patients with reduced Ejection Fraction, Change from baseline segmental movement of the territory revascularized measured by echocardiography
Changes in left ventricular ejection fraction (LVEF) 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
Trial Locations
- Locations (21)
Hospital General Universitario de Elche
🇪🇸Elche, Alicante, Spain
Hospital Universitario de Cruces
🇪🇸Barakaldo, Spain
Hospital de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hospital General Universitario de Castellón
🇪🇸Castelló, Spain
Hospital General Universitario de Ciudad Real
🇪🇸Ciudad Real, Spain
Hospital Universitario San Pedro de Alcántara
🇪🇸Cáceres, Spain
Hospital Universitari Dr. Josep Trueta
🇪🇸Girona, Spain
Hospital Universitario Clínico San Cecilio
🇪🇸Granada, Spain
Hospital Universitari Arnau de Vilanova
🇪🇸Lleida, Spain
Hospital Universitario de Leon
🇪🇸León, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital Parc Tauli
🇪🇸Sabadell, Spain
Hospital Clinico Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Clínico Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, Spain
Hospital Universitario de Toledo
🇪🇸Toledo, Spain
Hospital Universitario Y Politécnico La Fé
🇪🇸Valencia, Spain
Hospital Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Universitari Vall D'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario A Coruña
🇪🇸Coruña, Spain
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain