SUPRAFLEX CRUZ PMCF Study ( rEpic05 )

Ischemic Heart Disease Clinical Trial

— Multiflex  

Official title:

SUPRAFLEX CRUZPost-Market Clinical Follow-up Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05617599
• Other study ID #: rEpic05 - Multiflex
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

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