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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05617599
Other study ID # rEpic05 - Multiflex
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 10, 2023
Est. completion date October 1, 2025

Study information

Verified date March 2024
Source Fundación EPIC
Contact Bruno Garcia, MD, PhD
Phone 0034932746155
Email brunogb51@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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 information / eligibility

Status Recruiting
Enrollment 508
Est. completion date October 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Spain Hospital Universitario de Cruces Barakaldo
Spain Hospital de La Santa Creu I Sant Pau Barcelona
Spain Hospital Universitari Vall D'Hebron Barcelona
Spain Hospital Universitario San Pedro de Alcántara Cáceres
Spain Hospital General Universitario de Castellón Castelló
Spain Hospital General Universitario de Ciudad Real Ciudad Real
Spain Hospital Universitario A Coruña Coruña
Spain Hospital General Universitario de Elche Elche Alicante
Spain Hospital Universitari Dr. Josep Trueta Girona
Spain Hospital Universitario Clínico San Cecilio Granada
Spain Hospital Universitario de Leon León
Spain Hospital Universitari Arnau de Vilanova Lleida
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 Virgen Del Rocio Sevilla
Spain Hospital Universitario de Toledo Toledo
Spain Hospital Universitario Y Politécnico La Fé Valencia
Spain Hospital Universitario Lozano Blesa Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Bangalore S, Toklu B, Patel N, Feit F, Stone GW. Newer-Generation Ultrathin Strut Drug-Eluting Stents Versus Older Second-Generation Thicker Strut Drug-Eluting Stents for Coronary Artery Disease. Circulation. 2018 Nov 13;138(20):2216-2226. doi: 10.1161/CIRCULATIONAHA.118.034456. — View Citation

Lemos PA, Chandwani P, Saxena S, Ramachandran PK, Abhyankar A, Campos CM, Marchini JF, Galon MZ, Verma P, Sandhu MS, Parikh N, Bhupali A, Jain S, Prajapati J. Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry. BMJ Open. 2016 Feb 17;6(2):e010028. doi: 10.1136/bmjopen-2015-010028. — View Citation

Modolo R, Chichareon P, Kogame N, Asano T, Chang CC, de Winter RJ, Kaul U, Zaman A, Spitzer E, Takahashi K, Katagiri Y, Soliman OII, van Es GA, Morel MA, Onuma Y, Serruys PW. A prospective multicentre randomised all-comers trial to assess the safety and effectiveness of the thin-strut sirolimus-eluting coronary stent SUPRAFLEX: rationale and design of the Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent (TALENT) trial. EuroIntervention. 2019 Jul 20;15(4):e362-e369. doi: 10.4244/EIJ-D-18-00499. — View Citation

Zaman A, de Winter RJ, Kogame N, Chang CC, Modolo R, Spitzer E, Tonino P, Hofma S, Zurakowski A, Smits PC, Prokopczuk J, Moreno R, Choudhury A, Petrov I, Cequier A, Kukreja N, Hoye A, Iniguez A, Ungi I, Serra A, Gil RJ, Walsh S, Tonev G, Mathur A, Merkely B, Colombo A, Ijsselmuiden S, Soliman O, Kaul U, Onuma Y, Serruys PW; TALENT trial investigators. Safety and efficacy of a sirolimus-eluting coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial. Lancet. 2019 Mar 9;393(10175):987-997. doi: 10.1016/S0140-6736(18)32467-X. Epub 2019 Feb 28. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Target Lesion Failure (TLF) Rate of target lesion failure 12 months
Primary Device-oriented Composite Endpoint (DoCE) 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 12 months
Secondary Major Adverse Cardiovascular Event (MACE) Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke 12 months
Secondary Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography In the subgroup of patients with reduced Ejection Fraction, Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography 1 month
Secondary Change from baseline in Global Longitudinal Strain measured by strain-rate echocardiography In the subgroup of patients with reduced Ejection Fraction, Change from baseline in Global Longitudinal Strain measured by strain-rate echocardiography 1 month
Secondary Change of segmental movement of the territory revascularized measured by echocardiography In the subgroup of patients with reduced Ejection Fraction, Change from baseline segmental movement of the territory revascularized measured by echocardiography 1 month
Secondary Changes in left ventricular ejection fraction (LVEF) 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 1 month
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