Clinical trial NCT05617599: SUPRAFLEX CRUZ PMCF Study ( rEpic05 )
Official title: SUPRAFLEX CRUZPost-Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease (CAD)
Ischemic Heart Disease
Keywords: CE-MDR (Medical Device Regulations)
PMCF (Post-Market Clinical Follow-up)
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with MULTIFLEX PMCF according to routine hospital practice and following instructions for use

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.

Eligibility criteria: 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

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
measure: Device-oriented Composite Endpoint (DoCE)
timeFrame: 12 months
Secondary outcomes:
measure: Major Adverse Cardiovascular Event (MACE)
timeFrame: 12 months
measure: Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography
timeFrame: 1 month
measure: Change from baseline in Global Longitudinal Strain measured by strain-rate echocardiography
timeFrame: 1 month
measure: Change of segmental movement of the territory revascularized measured by echocardiography
timeFrame: 1 month
measure: Changes in left ventricular ejection fraction (LVEF)
timeFrame: 1 month
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Castelló
country: Spain
facility: Hospital General Universitario de Castellón
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Cáceres
country: Spain
facility: Hospital Universitario San Pedro de Alcántara
city: Girona
country: Spain
facility: Hospital Universitari Dr. Josep Trueta
city: Granada
country: Spain
facility: Hospital Universitario Clínico San Cecilio
city: León
country: Spain
facility: Hospital Universitario de Leon
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Sabadell
country: Spain
facility: Hospital Parc Tauli
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Toledo
country: Spain
facility: Hospital Universitario de Toledo
city: Valencia
country: Spain
facility: Hospital Universitario Y Politécnico La Fé
city: Zaragoza
country: Spain
facility: Hospital Universitario Lozano Blesa
Study officials:
References:
citation: 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.
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.
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.
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.