Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT03567733
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2018-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Registry of Patients Over 75 Years Old Treated With Xience Sierra Stents. Sierra 75 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2020-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-23', 'studyFirstSubmitDate': '2018-06-12', 'studyFirstSubmitQcDate': '2018-06-21', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). .', 'timeFrame': '12 month', 'description': 'The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).\n\n.'}, {'measure': 'Efficacy.The incidence of clinically driven target lesion revascularization (TLR).', 'timeFrame': '12 month', 'description': 'The incidence of clinically driven target lesion revascularization (TLR).'}], 'secondaryOutcomes': [{'measure': 'All death.', 'timeFrame': '12 month', 'description': 'All death.\n\nSystemic embolism, Major bleeding event (BARC ≥ 2)'}, {'measure': 'Cardiac death.', 'timeFrame': '12 month', 'description': 'Cardiac death.'}, {'measure': 'Target Vessel revascularization.', 'timeFrame': '12 month', 'description': 'Target Vessel revascularization.'}, {'measure': 'Target lesion revascularization.', 'timeFrame': '12 month', 'description': 'Target lesion revascularization.'}, {'measure': 'Stent thrombosis (ARC definite/probable).', 'timeFrame': '12 month', 'description': 'Stent thrombosis (ARC definite/probable).'}, {'measure': 'Major bleeding event (BARC type 2-5).', 'timeFrame': '12 month', 'description': 'Major bleeding event (BARC type 2-5).'}, {'measure': 'Stroke.', 'timeFrame': '12 month', 'description': 'Stroke.'}, {'measure': 'Procedural success.', 'timeFrame': '12 month', 'description': 'Procedural success ( Residual stenosis \\<30% after implantation at the narrowest point of the treated vascular segment).'}, {'measure': 'Rate of patients with DAPT.', 'timeFrame': '1 month', 'description': 'Rate of patients with DAPT.'}, {'measure': 'Rate of patients with DAPT.', 'timeFrame': 'From 1 to 3 months', 'description': 'Rate of patients with DAPT.'}, {'measure': 'Rate of patients with DAPT.', 'timeFrame': 'From 3 to 6 months', 'description': 'Rate of patients with DAPT.'}, {'measure': 'Rate of patients with DAPT.', 'timeFrame': 'From 6 to 12 months', 'description': 'Rate of patients with DAPT.'}, {'measure': 'Collection of imaging data by Optical coherence tomography (OCT).', 'timeFrame': '12 month', 'description': 'Collection of imaging data by OCT.'}, {'measure': 'Collection of imaging data by Intravascular Ultrasound (IVUS).', 'timeFrame': '12 month', 'description': 'Collection of imaging data by IVUS.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dual antiplatelet treatment', 'Elderly patients'], 'conditions': ['Ischemic Heart Disease', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '28290994', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '22995087', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24216285', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '24454326', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26466021', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28579168', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35722037', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.precisedaptscore.com/predapt/webcalculator.html', 'label': 'Related Info'}, {'url': 'https://doi.org/10.11909/j.issn.1671-5411.2022.05.009', 'label': 'Study Results'}]}, 'descriptionModule': {'briefSummary': 'This prospective registry is intended to evaluate the safety and efficacy of the XIENCE Sierra stent.', 'detailedDescription': 'This prospective registry is intended to analyze clinical outcomes in elderly patients treated with XIENCE Sierra stent and in pre-established subgroups (stable and unstable coronary artery disease).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients older than 75 years with de novo native coronary artery lesions, candidate to undergo revascularisation with a coronary device.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\> 75 years.\n* With indication of percutaneous revascularization.\n* Presence of de novo coronary artery lesions located in a native coronary artery.\n* Informed consent signed\n\nExclusion Criteria:\n\n* Cardiogenic shock at the time of the PCI(Percutaneous Coronary Intervention)\n* Cardiac arrest before the PCI\n* Life expectancy of the patient under 1 year\n* Participation in another study with a drug or device in clinical research\n* Clinical decision that excludes the use of drug-eluting stents\n* Confirmed allergy to aspirin and / or thienopyridines.'}, 'identificationModule': {'nctId': 'NCT03567733', 'acronym': 'SIERRA 75', 'briefTitle': 'Prospective Registry of Patients Over 75 Years Old Treated With Xience Sierra Stents. Sierra 75 Study', 'organization': {'class': 'OTHER', 'fullName': 'Fundación EPIC'}, 'officialTitle': 'Prospective Registry of Patients Over 75 Years Old Treated With Xience Sierra Stents". Sierra 75 Study', 'orgStudyIdInfo': {'id': 'SIERRA 75 EPIC-05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronary Artery Disease', 'description': 'Drug- eluting Stent', 'interventionNames': ['Device: XIENCE Sierra']}], 'interventions': [{'name': 'XIENCE Sierra', 'type': 'DEVICE', 'description': 'Percutaneous coronary intervention', 'armGroupLabels': ['Coronary Artery Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2805-267', 'city': 'Almada', 'country': 'Portugal', 'facility': 'Hospital Garcia de Orta', 'geoPoint': {'lat': 38.67902, 'lon': -9.1569}}, {'zip': '2790-134', 'city': 'Carnaxide', 'country': 'Portugal', 'facility': 'Centro Hospitalar Lisboa Occidental. Hospital de Santa Cruz', 'geoPoint': {'lat': 38.72706, 'lon': -9.24671}}, {'zip': '4401-860', 'city': 'Espinho', 'country': 'Portugal', 'facility': 'Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE', 'geoPoint': {'lat': 41.00763, 'lon': -8.64125}}, {'zip': '7000', 'city': 'Evora', 'country': 'Portugal', 'facility': 'Hospital do Espírito Santo de Évora', 'geoPoint': {'lat': 38.56587, 'lon': -7.90405}}, {'zip': '9500-370', 'city': 'Ponta Delgada', 'country': 'Portugal', 'facility': 'Hospital Do Divino Espirito Santo De Ponta Delgada', 'geoPoint': {'lat': 37.73952, 'lon': -25.66874}}, {'zip': '9500-370', 'city': 'Ponta Delgada', 'country': 'Portugal', 'facility': 'Hospital Do Divino Espirito Santo', 'geoPoint': {'lat': 37.73952, 'lon': -25.66874}}, {'zip': '2910-446', 'city': 'Setúbal', 'country': 'Portugal', 'facility': 'Centro Hospitalar de Setubal, EPE - Hospital Sao Bernardo', 'geoPoint': {'lat': 38.5244, 'lon': -8.8882}}, {'zip': '03293', 'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital Universitario Vinalopo', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'zip': '03186', 'city': 'Torrevieja', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital de Torrevieja', 'geoPoint': {'lat': 37.97872, 'lon': -0.68222}}, {'zip': '06800', 'city': 'Mérida', 'state': 'Badajoz', 'country': 'Spain', 'facility': 'Hospital de Mérida', 'geoPoint': {'lat': 38.91802, 'lon': -6.34292}}, {'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias I Pujol de Badalona', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '11510', 'city': 'Puerto Real', 'state': 'Cádiz', 'country': 'Spain', 'facility': 'Hospital de Puerto Real', 'geoPoint': {'lat': 36.52819, 'lon': -6.19011}}, {'zip': '07120', 'city': 'Palma de Mallorca', 'state': 'Mallorca', 'country': 'Spain', 'facility': 'Hospital Universitari Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '02006', 'city': 'Albacete', 'country': 'Spain', 'facility': 'Hospital General Universitario de Albacete', 'geoPoint': {'lat': 38.99424, 'lon': -1.85643}}, {'zip': '03550', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital Universitario San Juan de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '06080', 'city': 'Badajoz', 'country': 'Spain', 'facility': 'Hospital Infanta Cristina', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '48903', 'city': 'Barakaldo', 'country': 'Spain', 'facility': 'Hospital Universitario de Cruces', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall D'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '09006', 'city': 'Burgos', 'country': 'Spain', 'facility': 'Hospital Universitario de Burgos', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'zip': '11009', 'city': 'Cadiz', 'country': 'Spain', 'facility': 'Hospital Puerta Del Mar', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'zip': '48960', 'city': 'Galdakao', 'country': 'Spain', 'facility': 'Hospital Galdakao-Usansolo', 'geoPoint': {'lat': 43.23073, 'lon': -2.8429}}, {'zip': '33394', 'city': 'Gijón', 'country': 'Spain', 'facility': 'Hospital de Cabueñes', 'geoPoint': {'lat': 43.53573, 'lon': -5.66152}}, {'zip': '18014', 'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de Las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '21005', 'city': 'Huelva', 'country': 'Spain', 'facility': 'Hospital General Juan Ramón Jiménez', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'zip': '23007', 'city': 'Jaén', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Jaén', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'zip': '24080', 'city': 'León', 'country': 'Spain', 'facility': 'Hospital de León', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '27003', 'city': 'Lugo', 'country': 'Spain', 'facility': 'Hospital Universitario Lucus Augusti', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28222', 'city': 'Majadahonda', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro Majadahonda', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Complejo Hospitalario Regional de Málaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '30120', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario Virgen de La Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '31008', 'city': 'Pamplona', 'country': 'Spain', 'facility': 'Clinica Universidad de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '38010', 'city': 'Santa Cruz de Tenerife', 'country': 'Spain', 'facility': 'Hospital Nuestra Señora de la Candelaria', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '38320', 'city': 'Santa Cruz de Tenerife', 'country': 'Spain', 'facility': 'Hospital Universitario de Canarias', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Universitario Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '45004', 'city': 'Toledo', 'country': 'Spain', 'facility': 'Hospital Virgen de La Salud', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari I Politècnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '36312', 'city': 'Vigo', 'country': 'Spain', 'facility': 'Hospital Universitario Álvaro Cunqueiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '01009', 'city': 'Vitoria-Gasteiz', 'state': 'Álava', 'country': 'Spain', 'facility': 'Hospital Universitario de Araba', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación EPIC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}