SUPRAFLEX CRUZ PMCF Study ( rEpic05 )

NCT05617599 | Recruiting DMC

• 1 other identifier: rEpic05 - Multiflex
• Study Type: observational
• Target: 508
• Locations: 1 country
• Sites: 21

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).

Conditions

Coronary Artery Disease (CAD); Ischemic Heart Disease

Keywords

CE-MDR (Medical Device Regulations); PMCF (Post-Market Clinical Follow-up)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Major Adverse Cardiovascular Event (MACE)

  12 months

• 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

  1 month

• Change of segmental movement of the territory revascularized measured by echocardiography

  1 month

• Changes in left ventricular ejection fraction (LVEF)

  1 month

Study Arms (1)

Coronary Artery Disease (CAD)

Device: SUPRAFLEX CRUZ

Interventions

SUPRAFLEX CRUZ DEVICE

Patients in whom treatment with SUPRAFLEX CRUZ has been attempted

Coronary Artery Disease (CAD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ≥ 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

You may not qualify if:

• Contraindication for antiplatelet treatment
• Patient life expectancy less than 12 months

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (21)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

RECRUITING

Hospital Universitario A Coruña

A Coruña, 15006, Spain

RECRUITING

Hospital Universitario de Cruces

Barakaldo, 48903, Spain

RECRUITING

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital de La Santa Creu I Sant Pau

Barcelona, 08041, Spain

RECRUITING

Hospital General Universitario de Castellón

Castelló, 12004, Spain

RECRUITING

Hospital Universitario San Pedro de Alcántara

Cáceres, 10003, Spain

RECRUITING

Hospital General Universitario de Ciudad Real

Ciudad Real, 13005, Spain

RECRUITING

Hospital Universitari Dr. Josep Trueta

Girona, 17007, Spain

RECRUITING

Hospital Universitario Clínico San Cecilio

Granada, 18016, Spain

RECRUITING

Hospital Universitario de Leon

León, 24001, Spain

RECRUITING

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

RECRUITING

Hospital Parc Tauli

Sabadell, 08208, Spain

RECRUITING

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

RECRUITING

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, 15706, Spain

RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

RECRUITING

Hospital Universitario de Toledo

Toledo, 45007, Spain

RECRUITING

Hospital Universitario Y Politécnico La Fé

Valencia, 46026, Spain

RECRUITING

Hospital Universitario Lozano Blesa

Zaragoza, 50009, Spain

RECRUITING

Related 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.

  PMID: 29945934 BACKGROUND

• 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.

  PMID: 26888727 BACKGROUND

• 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.

  PMID: 30066672 BACKGROUND

• 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.

  PMID: 30827782 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Bruno Garcia, MD, PhD

CONTACT

0034932746155; brunogb51@gmail.com

FUNDACION EPIC

CONTACT

0034987225638; iepic@fundacionepic.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 15, 2022
• Study Start: May 10, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

ES (21)