Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-01-24 @ 11:06 PM
Study NCT ID:
NCT01466634
Status:
COMPLETED
Last Update Posted:
2011-11-08
First Post:
2011-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioabsorbable Versus Durable Polymer Drug Eluting Stent (DES): a Meta-analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}, {'id': 'D015607', 'term': 'Stents'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-04', 'studyFirstSubmitDate': '2011-10-24', 'studyFirstSubmitQcDate': '2011-11-04', 'lastUpdatePostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'late coronary lumen loss', 'timeFrame': '9 month'}, {'measure': 'target lesion revascularization', 'timeFrame': '9 month'}, {'measure': 'overall mortality', 'timeFrame': '1 year'}, {'measure': 'Late stent thrombosis', 'timeFrame': '1 year'}, {'measure': 'Myocardial Infarction', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Binary restenosis', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Restenosis', 'Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '23152364', 'type': 'DERIVED', 'citation': 'Lupi A, Rognoni A, Secco GG, Lazzero M, Nardi F, Fattori R, Bongo AS, Agostoni P, Sheiban I. Biodegradable versus durable polymer drug eluting stents in coronary artery disease: insights from a meta-analysis of 5,834 patients. Eur J Prev Cardiol. 2014 Apr;21(4):411-24. doi: 10.1177/2047487312467745. Epub 2012 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'Evidence supporting use of bioabsorbable polymer drug eluting stents (BP-DES) is uncertain. Thus the investigators planned a meta-analysis to compare outcomes of BP-DES versus PP-DES in obstructive coronary artery disease.', 'detailedDescription': 'Evidence supporting use of bioabsorbable polymer drug eluting stents (BP-DES) is uncertain. Previous studies suggested that BP-DES are at least as effective as durable polymer drug eluting stents (PP-DES). Thus the investigators planned a meta-analysis to compare outcomes of BP-DES versus PP-DES in obstructive coronary artery disease. Medline and Web databases were searched for studies comparing BP-DES and PP-DES for obstructive coronary disease, reporting rates of overall mortality, target lesion revascularization (TLR), myocardial infarction (MI), binary restenosis and late lumen loss (LLL) with a follow-up ≥ 6 months. Odds ratios (ORs) will be computed from individual studies and pooled according to a fixed effect (e.g. inverse variance weighting) or random effect model in case of statistical heterogeneity. Given the a priori heterogeneous nature of the observational analyses, separate subgroup analysis of studies with PLA bioabsorbable polymer loaded with biolimus A19 (BP-BES) is prespecified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary artery disease with indication to percutaneous coronary intervention', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* randomized studies\n* studies reporting clinical outcomes as overall death and/or acute myocardial infarction and/or late stent thrombosis (ARC definition)\\[\\*\\*\\] and/or target lesion revascularization and/or late lumen loss\n* follow up period longer than 6 months.\n\nExclusion Criteria:\n\n* duplicate reporting (in which case the manuscript reporting the largest sample or the longest follow-up was selected)\n* inability to compute risk estimates due to absence of clinical event in one of the groups\n* studies presenting composite major adverse cardiac event (MACE) and not individual end points.'}, 'identificationModule': {'nctId': 'NCT01466634', 'briefTitle': 'Bioabsorbable Versus Durable Polymer Drug Eluting Stent (DES): a Meta-analysis', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero Universitaria Maggiore della Carita'}, 'officialTitle': 'Bioabsorbable Versus Permanent Polymer Bare Metal Stents in Saphenous Vein Graft Disease: Insights From a Meta-analysis of 6221 Patients', 'orgStudyIdInfo': {'id': '010101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'permanent polymer DES', 'interventionNames': ['Procedure: percutaneous coronary intervention with stent']}, {'label': 'bioabsorbable polymer DES', 'interventionNames': ['Procedure: percutaneous coronary intervention with stent']}], 'interventions': [{'name': 'percutaneous coronary intervention with stent', 'type': 'PROCEDURE', 'description': 'patients with coronary artery disease treated by percutaneous coronary intervention with BP-DES are compared with patients with coronary artery disease treated by percutaneous coronary intervention with PP-DES', 'armGroupLabels': ['bioabsorbable polymer DES', 'permanent polymer DES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'facility': 'Ospedale Maggiore della Carità', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}], 'overallOfficials': [{'name': 'Alessandro Lupi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AOU Maggiore della Carita'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero Universitaria Maggiore della Carita', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Lupi Alessandro', 'investigatorAffiliation': 'Azienda Ospedaliero Universitaria Maggiore della Carita'}}}}