Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT01472705
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2011-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Everolimus- Versus Biolimus-Eluting Stents in All-Comers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 814}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2011-08-30', 'studyFirstSubmitQcDate': '2011-11-13', 'lastUpdatePostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of Death, Myocardial Infarction and Target Vessel Revascularization', 'timeFrame': 'up to 24 months', 'description': 'The primary outcome is the above mentioned composite of adverse events in order to measure their cumulative incidence (i.e. the rate of occurrence of such events in the study population over a predefined time periode).'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular death', 'timeFrame': 'up to 24 months'}, {'measure': 'Any Revascularization', 'timeFrame': 'up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['drug-eluting coronary stent', 'percutaneous coronary intervention'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '23482296', 'type': 'RESULT', 'citation': 'Puricel S, Oberhansli M, Guntern P, Lehmann S, Goy JJ, Arroyo D, Villeneuve H, Baeriswyl G, Stauffer JC, Togni M, Cook S. Long-term comparison of everolimus-eluting and biolimus-eluting stents. EuroIntervention. 2013 Jul;9(3):336-44. doi: 10.4244/EIJV9I3A55.'}, {'pmid': '24398143', 'type': 'RESULT', 'citation': 'Arroyo D, Togni M, Puricel S, Gerard B, Sonja L, Corpataux N, Villeneuve H, Boute E, Stauffer JC, Goy JJ, Cook S. Comparison of everolimus-eluting and biolimus-eluting coronary stents with everolimus-eluting bioresorbable scaffold: study protocol of the randomized controlled EVERBIO II trial. Trials. 2014 Jan 7;15:9. doi: 10.1186/1745-6215-15-9.'}]}, 'descriptionModule': {'briefSummary': 'This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with biodegradable polymer as compared with everolimus-eluting stents (EES) with durable polymer through 3 years of follow-up.', 'detailedDescription': 'A group of 814 consecutive patients undergoing percutaneous coronary intervention (PCI) was enrolled between 2007 and 2010, of which 527 were treated with EES and 287 with BES implantation. Clinical outcome was compared in 200 pairs using propensity score matching. The primary endpoint was a composite of death, myocardial infarction (MI) and target vessel revascularisation (TVR) at two-year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients treated at our institution with at least one BES or EES', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients with at least one BES or EES for de novo stenosis\n\nExclusion Criteria:\n\n* patients with at least one non-study stent\n* patients with both study stent\n* patients with life expectancy \\< 3 years'}, 'identificationModule': {'nctId': 'NCT01472705', 'acronym': 'EverBio', 'briefTitle': 'Everolimus- Versus Biolimus-Eluting Stents in All-Comers', 'organization': {'class': 'OTHER', 'fullName': 'University of Freiburg'}, 'officialTitle': 'Long-Term Comparison of Everolimus-Eluting and Biolimus-Eluting Stents in All-Comer Patients', 'orgStudyIdInfo': {'id': '003-REP-CER-FR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'everolimus-eluting stents (EES)', 'description': 'Second-generation everolimus-eluting stents (EES) have been shown to be superior to the first-generation paclitaxel eluting stents (PES) in terms of safety and efficacy.'}, {'label': 'biolimus-eluting stents (BES)', 'description': 'Third generation biolimus-eluting stents (BES) have been shown to be superior to the PES and non inferior to first-generation sirolimus eluting stents in terms of safety and efficacy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1708', 'city': 'Fribourg', 'state': 'Canton of Fribourg', 'country': 'Switzerland', 'facility': 'Cardiology, university Fribourg Medical Center', 'geoPoint': {'lat': 46.80237, 'lon': 7.15128}}], 'overallOfficials': [{'name': 'Stéphane P Cook, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Fribourg'}, {'name': 'Mario Togni, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Fribourg'}, {'name': 'Markus Oberhänsli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Fribourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Freiburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stéphane Cook, Prof', 'investigatorAffiliation': 'University of Freiburg'}}}}