Coronary Artery Disease (CAD), Ischemic Heart Disease
Conditions
Keywords
CE-MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up)
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.
Interventions
DEVICESUPRAFLEX CRUZ
Patients in whom treatment with SUPRAFLEX CRUZ has been attempted
Sponsors
Fundación EPIC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Major Adverse Cardiovascular Event (MACE) | 12 months | Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke |
| 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 |
| 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 |
| 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 |
Countries
Spain
Contacts
Primary ContactBruno Garcia, MD, PhD
Backup ContactFUNDACION EPIC
Outcome results
None listed