SUPRAFLEX CRUZ PMCF Study ( rEpic05 ) (Multiflex)

SUPRAFLEX CRUZPost-Market Clinical Follow-up Study

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).

Study Overview

• Status: Recruiting
• Conditions: Ischemic Heart Disease; Coronary Artery Disease (CAD)
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Estimated): 508

Contacts and Locations

• Study Contact: Name: Bruno Garcia, MD, PhD; Phone Number: 0034932746155; Email: brunogb51@gmail.com
• Study Contact Backup: Name: FUNDACION EPIC; Phone Number: 0034987225638; Email: iepic@fundacionepic.org

Study Locations

• Spain
  • Barakaldo, Spain, 48903
    • Recruiting
    • Hospital Universitario de Cruces
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital de La Santa Creu I Sant Pau
  • Castelló, Spain, 12004
    • Recruiting
    • Hospital General Universitario de Castellón
  • Ciudad Real, Spain, 13005
    • Recruiting
    • Hospital General Universitario De Ciudad Real
  • Coruña, Spain, 15006
    • Recruiting
    • Hospital Universitario A Coruna
  • Cáceres, Spain, 10003
    • Recruiting
    • Hospital Universitario San Pedro de Alcántara
  • Girona, Spain, 17007
    • Recruiting
    • Hospital Universitari Dr. Josep Trueta
  • Granada, Spain, 18016
    • Recruiting
    • Hospital Universitario Clínico San Cecilio
  • León, Spain, 24001
    • Recruiting
    • Hospital Universitario de León
  • Lleida, Spain, 25198
    • Recruiting
    • Hospital Universitari Arnau de Vilanova
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
  • Murcia, Spain, 30120
    • Recruiting
    • Hospital Clinico Universitario Virgen de la Arrixaca
  • Sabadell, Spain, 08208
    • Recruiting
    • Hospital Parc Tauli
  • Salamanca, Spain, 37007
    • Recruiting
    • Hospital Clínico Universitario de Salamanca
  • Santiago de Compostela, Spain, 15706
    • Recruiting
    • Hospital Clinico Universitario de Santiago de Compostela
  • Sevilla, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen Del Rocio
  • Toledo, Spain, 45007
    • Recruiting
    • Hospital Universitario de Toledo
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitario y Politécnico La Fe
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Universitario Lozano Blesa
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Recruiting
      • Hospital General Universitario de Elche

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with MULTIFLEX PMCF according to routine hospital practice and following instructions for use

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coronary Artery Disease (CAD)	Device: SUPRAFLEX CRUZ; Patients in whom treatment with SUPRAFLEX CRUZ has been attempted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure (TLF)	Rate of target lesion failure	12 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular Event (MACE)	Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke	12 months
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
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
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
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

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: PMCF (Post-Market Clinical Follow-up); CE-MDR (Medical Device Regulations)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: rEpic05 - Multiflex