Prospective Registry of Patients Over 75 Years Old Treated With Xience Sierra Stents. Sierra 75 Study
NCT ID: NCT03567733
Last Updated: 2025-08-29
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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COMPLETED
1000 participants
OBSERVATIONAL
2018-06-18
2020-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Coronary Artery Disease
Drug- eluting Stent
XIENCE Sierra
Percutaneous coronary intervention
Interventions
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XIENCE Sierra
Percutaneous coronary intervention
Eligibility Criteria
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Inclusion Criteria
* With indication of percutaneous revascularization.
* Presence of de novo coronary artery lesions located in a native coronary artery.
* Informed consent signed
Exclusion Criteria
* Cardiac arrest before the PCI
* Life expectancy of the patient under 1 year
* Participation in another study with a drug or device in clinical research
* Clinical decision that excludes the use of drug-eluting stents
* Confirmed allergy to aspirin and / or thienopyridines.
75 Years
ALL
No
Sponsors
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Fundación EPIC
OTHER
Responsible Party
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Locations
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Hospital Garcia de Orta
Almada, , Portugal
Centro Hospitalar Lisboa Occidental. Hospital de Santa Cruz
Carnaxide, , Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
Espinho, , Portugal
Hospital do Espírito Santo de Évora
Evora, , Portugal
Hospital Do Divino Espirito Santo De Ponta Delgada
Ponta Delgada, , Portugal
Hospital Do Divino Espirito Santo
Ponta Delgada, , Portugal
Centro Hospitalar de Setubal, EPE - Hospital Sao Bernardo
Setúbal, , Portugal
Hospital Universitario Vinalopo
Elche, Alicante, Spain
Hospital de Torrevieja
Torrevieja, Alicante, Spain
Hospital de Mérida
Mérida, Badajoz, Spain
Hospital Universitari Germans Trias I Pujol de Badalona
Badalona, Barcelona, Spain
Hospital de Puerto Real
Puerto Real, Cádiz, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Mallorca, Spain
Hospital General Universitario de Albacete
Albacete, , Spain
Hospital Universitario San Juan de Alicante
Alicante, , Spain
Hospital Infanta Cristina
Badajoz, , Spain
Hospital Universitario de Cruces
Barakaldo, , Spain
Hospital Universitari Vall D'Hebron
Barcelona, , Spain
Hospital Universitario de Burgos
Burgos, , Spain
Hospital Puerta Del Mar
Cadiz, , Spain
Hospital Galdakao-Usansolo
Galdakao, , Spain
Hospital de Cabueñes
Gijón, , Spain
Hospital Universitario Virgen de Las Nieves
Granada, , Spain
Hospital General Juan Ramón Jiménez
Huelva, , Spain
Complejo Hospitalario de Jaén
Jaén, , Spain
Hospital de León
León, , Spain
Hospital Universitario Lucus Augusti
Lugo, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Complejo Hospitalario Regional de Málaga
Málaga, , Spain
Hospital Clinico Universitario Virgen de La Arrixaca
Murcia, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, , Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Virgen de La Salud
Toledo, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Universitari I Politècnic La Fe
Valencia, , Spain
Hospital Universitario Álvaro Cunqueiro
Vigo, , Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Hospital Universitario de Araba
Vitoria-Gasteiz, Álava, Spain
Countries
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References
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Costa F, van Klaveren D, James S, Heg D, Raber L, Feres F, Pilgrim T, Hong MK, Kim HS, Colombo A, Steg PG, Zanchin T, Palmerini T, Wallentin L, Bhatt DL, Stone GW, Windecker S, Steyerberg EW, Valgimigli M; PRECISE-DAPT Study Investigators. Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials. Lancet. 2017 Mar 11;389(10073):1025-1034. doi: 10.1016/S0140-6736(17)30397-5.
Valgimigli M, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2017 Aug 26
Kedhi E, Stone GW, Kereiakes DJ, Serruys PW, Parise H, Fahy M, Simonton CA, Sudhir K, Sood P, Smits PC. Stent thrombosis: insights on outcomes, predictors and impact of dual antiplatelet therapy interruption from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE trials. EuroIntervention. 2012 Sep;8(5):599-606. doi: 10.4244/EIJV8I5A92.
de Belder A, de la Torre Hernandez JM, Lopez-Palop R, O'Kane P, Hernandez Hernandez F, Strange J, Gimeno F, Cotton J, Diaz Fernandez JF, Carrillo Saez P, Thomas M, Pinar E, Curzen N, Baz JA, Cooter N, Lozano I, Skipper N, Robinson D, Hildick-Smith D; XIMA Investigators. A prospective randomized trial of everolimus-eluting stents versus bare-metal stents in octogenarians: the XIMA Trial (Xience or Vision Stents for the Management of Angina in the Elderly). J Am Coll Cardiol. 2014 Apr 15;63(14):1371-5. doi: 10.1016/j.jacc.2013.10.053. Epub 2013 Nov 21.
Gao L, Hu X, Liu YQ, Xue Q, Wang Y. Comparison of coronary DES and BMS in octogenarians: A systematic review and meta-analysis. J Geriatr Cardiol. 2013 Dec;10(4):336-43. doi: 10.3969/j.issn.1671-5411.2013.04.004.
Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrie D, Naber C, Lipiecki J, Richardt G, Iniguez A, Brunel P, Valdes-Chavarri M, Garot P, Talwar S, Berland J, Abdellaoui M, Eberli F, Oldroyd K, Zambahari R, Gregson J, Greene S, Stoll HP, Morice MC; LEADERS FREE Investigators. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. N Engl J Med. 2015 Nov 19;373(21):2038-47. doi: 10.1056/NEJMoa1503943. Epub 2015 Oct 14.
Morice MC, Talwar S, Gaemperli O, Richardt G, Eberli F, Meredith I, Zaman A, Fajadet J, Copt S, Greene S, Urban P. Drug-coated versus bare-metal stents for elderly patients: A predefined sub-study of the LEADERS FREE trial. Int J Cardiol. 2017 Sep 15;243:110-115. doi: 10.1016/j.ijcard.2017.04.079. Epub 2017 Apr 25.
de la Torre Hernandez JM, Palop RL, Jimenez Mazuecos JM, Saez PC, Gutierez-Barrios A, Pinar E, Cid B, Fernandez L, Camarero TG, Urbano-Carrillo C, Oteo Dominguez JF, Jimenez Diaz VA, Gomez Menchero AE, Fernandez EG, Cordoba Soriano JG, Ocaranza R, Ucar EA, Roman KGS, Leal S, Caceres GM, Linares Vicente JA, Ferre GF, Carrillo X, Rama Merchan JC, Costa C, Sanchis J, Fernandes R, Rodrigues A, Vegas Valle JM, Pereira H, de Prado AP. Prospective application of a bleeding and ischemic risks-adjusted antithrombotic protocol in elderly patients revascularized with everolimus-eluting stents: EPIC05-Sierra75 study. J Geriatr Cardiol. 2022 May 28;19(5):354-366. doi: 10.11909/j.issn.1671-5411.2022.05.009.
Related Links
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Study Results
Other Identifiers
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SIERRA 75 EPIC-05
Identifier Type: -
Identifier Source: org_study_id
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