Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
508 participants
OBSERVATIONAL
2023-05-10
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Coronary Artery Disease (CAD)
SUPRAFLEX CRUZ
Patients in whom treatment with SUPRAFLEX CRUZ has been attempted
Interventions
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SUPRAFLEX CRUZ
Patients in whom treatment with SUPRAFLEX CRUZ has been attempted
Eligibility Criteria
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Inclusion Criteria
* 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
* Contraindication for antiplatelet treatment
* Patient life expectancy less than 12 months
18 Years
ALL
No
Sponsors
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Fundación EPIC
OTHER
Responsible Party
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Locations
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Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Universitario A Coruña
A Coruña, , Spain
Hospital Universitario de Cruces
Barakaldo, , Spain
Hospital Universitari Vall D'Hebron
Barcelona, , Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Hospital General Universitario de Castellón
Castelló, , Spain
Hospital Universitario San Pedro de Alcántara
Cáceres, , Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, , 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
Seville, , Spain
Hospital Universitario de Toledo
Toledo, , Spain
Hospital Universitario Y Politécnico La Fé
Valencia, , Spain
Hospital Universitario Lozano Blesa
Zaragoza, , Spain
Countries
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Central Contacts
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References
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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.
Other Identifiers
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rEpic05 - Multiflex
Identifier Type: -
Identifier Source: org_study_id