Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 1:36 PM
Study NCT ID:
NCT01500434
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2011-12-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of Long De Novo Coronary Artery Lesions (PLATINUM LL)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'C446540', 'term': 'thienopyridine'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ruth.starzyk@bsci.com', 'phone': '508-683-6577', 'title': 'Ruth Starzyk, PhD', 'organization': 'Boston Scientific'}, 'certainAgreement': {'otherDetails': 'The Principal Investigator shall have the right to publish the results, provided that before publishing, the PI shall submit copies of any proposed publication or presentation to Sponsor for review at least sixty (60) days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent', 'otherNumAtRisk': 102, 'otherNumAffected': 33, 'seriousNumAtRisk': 102, 'seriousNumAffected': 34}], 'otherEvents': [{'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Salivary gland cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arterial thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Therapeutic agent toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Prostatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Target Lesion Failure (TLF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Target Lesion Failure Rate', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '3.2', 'ciUpperLimit': '7.96', 'groupDescription': 'A one-group exact binomial test was used to test the hypothesis that the primary endpoint rate in the PROMUS Element cohort is less than the predefined performance goal of 19.4%.', 'statisticalMethod': 'One-group exact binomial test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Study had 85% statistical power to demonstrate that the 12-month rate for TLF (accounting for an expected 1-year attrition rate of 5%) is less than the performance goal, assuming a 1-year TLF rate of 9.0%.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis set for comparison of the primary endpoint, 12-month TLF, to the predefined performance goal of 21.1% (based on historical TAXUS Express results) is the per-protocol analysis set. All enrolled participants who received a PROMUS Element stent are included in the per-protocol analysis set.'}, {'type': 'SECONDARY', 'title': 'Target Lesion Failure (TLF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants underwent clinical follow-up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Target Lesion Failure (TLF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Months', 'description': 'TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'All Cause Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'All Cause Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'All Cause Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Cardiac Death Related to the Target Vessel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Cardiac Death Related to the Target Vessel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Cardiac Death Related to the Target Vessel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction (MI) Related to the Target Vessel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin \\>normal; if no new Q-waves total CK levels \\>3×normal (peri-percutaneous coronary intervention\\[PCI\\]) or \\>2×normal (spontaneous) with elevated CK-MB or troponin \\>3×normal (peri-PCI) or \\>2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin \\>5×normal', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction (MI) Related to the Target Vessel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin \\>normal; if no new Q-waves total CK levels \\>3×normal (peri-percutaneous coronary intervention\\[PCI\\]) or \\>2×normal (spontaneous) with elevated CK-MB or troponin \\>3×normal (peri-PCI) or \\>2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin \\>5×normal', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction (MI) Related to the Target Vessel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin \\>normal; if no new Q-waves total CK levels \\>3×normal (peri-percutaneous coronary intervention\\[PCI\\]) or \\>2×normal (spontaneous) with elevated CK-MB or troponin \\>3×normal (peri-PCI) or \\>2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin \\>5×normal', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Target Vessel Revascularization (TVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Target Vessel Revascularization (TVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Target Vessel Revascularization (TVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'description': 'DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \\>24 hours to 30 days post; late ST: \\>30 days to 1 year post; Very late ST: \\>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '>24 hours-30 days', 'description': 'DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \\>24 hours to 30 days post; late ST: \\>30 days to 1 year post; Very late ST: \\>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '31-365 days', 'description': 'DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \\>24 hours to 30 days post; late ST: \\>30 days to 1 year post; Very late ST: \\>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Acute Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}, {'units': 'stents', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Index Procedure', 'description': 'Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent', 'unitOfMeasure': 'percentage of stents', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'stents', 'denomUnitsSelected': 'stents', 'populationDescription': 'Analysis was intention to treat'}, {'type': 'SECONDARY', 'title': 'Clinical Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'In hospital (average of 1-2 days post index procedure)', 'description': 'Defined as mean lesion diameter stenosis \\<30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital MI, TVR, or cardiac death', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Missed 12-month follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Enrollment of 102 patients was planned and 102 patients were enrolled at 30 sites in Australia, Belgium, France, Japan, Latvia, New Zealand, and the United States from February 10, 2009 to March 4, 2010.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.9', 'spread': '9.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Black of African Heritage', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participant'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Latvia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cardiac History', 'classes': [{'title': 'Previous Percutaneous Coronary Intervention (PCI)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}, {'title': 'Previous Coronary Artery Bypass Graft (CABG)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Previous Myocardial Infarction (MI)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}, {'title': 'Congestive Heart Failure', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Stable Angina', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}, {'title': 'Unstable Angina', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'Silent Ischemia', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group.', 'unitOfMeasure': 'Participants'}, {'title': 'Cardiac History: Ejection Fraction', 'classes': [{'categories': [{'measurements': [{'value': '59.09', 'spread': '11.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cardiac Risk Factors', 'classes': [{'title': 'Smoking, Ever', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}, {'title': 'Medically Treated Diabetes', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'Hyperlipidemia Requiring Medication', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}]}]}, {'title': 'Hypertension Requiring Medication', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}]}]}, {'title': 'Family History of Coronary Artery Disease', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group.', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbidities', 'classes': [{'title': 'History of Peripheral Vascular Disease', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'History of Transient Ischemic Attack', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'History of Cerebrovascular Accident', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'History of Renal Disease', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'History of Gastrointestinal Bleeding', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group.', 'unitOfMeasure': 'Participants'}, {'title': 'Lesion Characteristic: Target Lesion Vessel', 'classes': [{'title': 'Left Anterior Descending Artery', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}, {'title': 'Left Circumflex Artery', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'Right Coronary Artery', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Lesions'}, {'title': 'Lesion Characteristic: Lesion Location', 'classes': [{'title': 'Ostial', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Proximal', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}, {'title': 'Mid', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}, {'title': 'Distal', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Lesions'}, {'title': 'Lesion Characteristics', 'classes': [{'title': 'Reference Vessel Diameter', 'categories': [{'measurements': [{'value': '2.56', 'spread': '0.40', 'groupId': 'BG000'}]}]}, {'title': 'Minimum Lumen Diameter', 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.30', 'groupId': 'BG000'}]}]}, {'title': 'Lesion Length', 'categories': [{'measurements': [{'value': '24.38', 'spread': '8.21', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lesion Characteristic: Percent Diameter Stenosis', 'classes': [{'categories': [{'measurements': [{'value': '71.70', 'spread': '10.96', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lesion Characteristics', 'classes': [{'title': 'Eccentric Lesion', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}, {'title': '> 45 Degree Bend', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}, {'title': '> 90 Degree Bend', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Tortuosity, any', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Calcification, any', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}, {'title': 'Total Occlusion', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Bifurcation', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Lesions'}, {'title': 'Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class', 'classes': [{'title': 'Type A', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Type B1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Type B2', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Type C', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Type A lesions: minimally complex, readily accessible, non-angulated, smooth contour, little to no calcification, less than totally occlusive, not ostial in location, no major side branch involvement, and an absence of thrombus.\n\nType B lesions: moderately complex, eccentric, moderate tortuosity and angulation, moderate or heavy calcification, total occlusion \\< 3 months old, ostial in location, with presence of thrombus.\n\nType C lesions: severely complex, diffuse, excessive tortuosity and angulation, total occlusions \\> 3 months old, degenerated vein grafts and friable lesions.', 'unitOfMeasure': 'Lesions'}, {'title': 'Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow', 'classes': [{'title': 'TIMI 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'TIMI 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'TIMI 2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'TIMI 3', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'TIMI 0 - No perfusion; TIMI 1 - Penetration with minimal perfusion; TIMI 2 - Partial perfusion; TIMI 3 - Complete perfusion', 'unitOfMeasure': 'Lesions'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-13', 'studyFirstSubmitDate': '2011-12-22', 'resultsFirstSubmitDate': '2012-01-11', 'studyFirstSubmitQcDate': '2011-12-22', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-01-11', 'studyFirstPostDateStruct': {'date': '2011-12-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Lesion Failure (TLF)', 'timeFrame': '12 months', 'description': 'Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.'}], 'secondaryOutcomes': [{'measure': 'Target Lesion Failure (TLF)', 'timeFrame': '30 Days', 'description': 'TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.'}, {'measure': 'Target Lesion Failure (TLF)', 'timeFrame': '6 Months', 'description': 'TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.'}, {'measure': 'Target Vessel Failure (TVF)', 'timeFrame': '30 Days', 'description': 'TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.'}, {'measure': 'Target Vessel Failure (TVF)', 'timeFrame': '6 months', 'description': 'TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.'}, {'measure': 'Target Vessel Failure (TVF)', 'timeFrame': '12 months', 'description': 'TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.'}, {'measure': 'All Cause Death', 'timeFrame': '30 Days'}, {'measure': 'All Cause Death', 'timeFrame': '6 months'}, {'measure': 'All Cause Death', 'timeFrame': '12 months'}, {'measure': 'Cardiac Death Related to the Target Vessel', 'timeFrame': '30 Days', 'description': 'Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded'}, {'measure': 'Cardiac Death Related to the Target Vessel', 'timeFrame': '6 months', 'description': 'Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded'}, {'measure': 'Cardiac Death Related to the Target Vessel', 'timeFrame': '12 months', 'description': 'Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded'}, {'measure': 'Myocardial Infarction (MI) Related to the Target Vessel', 'timeFrame': '30 Days', 'description': 'New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin \\>normal; if no new Q-waves total CK levels \\>3×normal (peri-percutaneous coronary intervention\\[PCI\\]) or \\>2×normal (spontaneous) with elevated CK-MB or troponin \\>3×normal (peri-PCI) or \\>2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin \\>5×normal'}, {'measure': 'Myocardial Infarction (MI) Related to the Target Vessel', 'timeFrame': '6 months', 'description': 'New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin \\>normal; if no new Q-waves total CK levels \\>3×normal (peri-percutaneous coronary intervention\\[PCI\\]) or \\>2×normal (spontaneous) with elevated CK-MB or troponin \\>3×normal (peri-PCI) or \\>2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin \\>5×normal'}, {'measure': 'Myocardial Infarction (MI) Related to the Target Vessel', 'timeFrame': '12 months', 'description': 'New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin \\>normal; if no new Q-waves total CK levels \\>3×normal (peri-percutaneous coronary intervention\\[PCI\\]) or \\>2×normal (spontaneous) with elevated CK-MB or troponin \\>3×normal (peri-PCI) or \\>2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin \\>5×normal'}, {'measure': 'Target Lesion Revascularization (TLR)', 'timeFrame': '30 days', 'description': 'TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.'}, {'measure': 'Target Lesion Revascularization (TLR)', 'timeFrame': '6 months', 'description': 'TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.'}, {'measure': 'Target Lesion Revascularization (TLR)', 'timeFrame': '12 months', 'description': 'TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.'}, {'measure': 'Target Vessel Revascularization (TVR)', 'timeFrame': '30 days', 'description': 'TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.'}, {'measure': 'Target Vessel Revascularization (TVR)', 'timeFrame': '6 months', 'description': 'TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.'}, {'measure': 'Target Vessel Revascularization (TVR)', 'timeFrame': '12 months', 'description': 'TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.'}, {'measure': 'Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition', 'timeFrame': '24 hours', 'description': 'DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \\>24 hours to 30 days post; late ST: \\>30 days to 1 year post; Very late ST: \\>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)'}, {'measure': 'Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition', 'timeFrame': '>24 hours-30 days', 'description': 'DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \\>24 hours to 30 days post; late ST: \\>30 days to 1 year post; Very late ST: \\>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)'}, {'measure': 'Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition', 'timeFrame': '31-365 days', 'description': 'DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \\>24 hours to 30 days post; late ST: \\>30 days to 1 year post; Very late ST: \\>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)'}, {'measure': 'Acute Technical Success', 'timeFrame': 'Index Procedure', 'description': 'Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent'}, {'measure': 'Clinical Procedural Success', 'timeFrame': 'In hospital (average of 1-2 days post index procedure)', 'description': 'Defined as mean lesion diameter stenosis \\<30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital MI, TVR, or cardiac death'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['drug-eluting stents', 'DES', 'atherosclerotic'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '29217001', 'type': 'DERIVED', 'citation': 'Kelly CR, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Rabinowitz A, Carrie D, Pompili V, Bouchard A, Saito S, Allocco DJ, Dawkins KD, Stone GW. Long-Term Safety and Efficacy of Platinum Chromium Everolimus-Eluting Stents in Coronary Artery Disease: 5-Year Results From the PLATINUM Trial. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2392-2400. doi: 10.1016/j.jcin.2017.06.070.'}, {'pmid': '24905795', 'type': 'DERIVED', 'citation': 'Teirstein PS, Meredith IT, Feldman RL, Rabinowitz AC, Cannon LA, Lee TC, Dens J, Dubois CL, Mooney MR, Pompili VJ, Saito S, Allocco DJ, Dawkins KD, Stone GW. Two-year safety and effectiveness of the platinum chromium everolimus-eluting stent for the treatment of small vessels and longer lesions. Catheter Cardiovasc Interv. 2015 Feb 1;85(2):207-15. doi: 10.1002/ccd.25565. Epub 2014 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions. The lesions can be longer than average-sized.', 'detailedDescription': 'The wide-spread use of drug-eluting stents (DES) has evolved as standard of care in de novo lesions. The proposed study will evaluate the safety and effectiveness of PROMUS Element for the treatment of de novo atherosclerotic lesions in native coronary arteries. The study design is consistent with the draft guidance for industry titled, "Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies" (March 2008).\n\nDuring the trial, thienopyridines must be administered according to the 2007 American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines, which recommended that clopidogrel (75 mg daily) or ticlopidine (250 mg twice daily) be prescribed after stent implantation for at least 6 months in all patients, and for at least 12 months in patients who are not at high risk of bleeding. For sites in the United States, the use of prasugrel is not allowed as part of the PLATINUM Clinical Trial. For sites in other countries, prasugrel may be prescribed according to its approved dosing in countries in which it is available. For patients taking aspirin daily a loading dose is recommended; for patients who have not been taking aspirin daily, aspirin must be administered as a loading dose. Patients continue to take aspirin indefinitely to reduce the risk of thrombosis.\n\nThis PLATINUM Long Lesion study is a sub-trial associated with the PLATINUM Workhorse Randomized Controlled Trial, which is registered under NCT00823212.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient must be at least 18 years of age\n* Patient (or legal guardian) understands study requirements and treatment procedures and provides written informed consent before any study-specific tests or procedures are performed\n* For patients less than 20 years of age enrolled at a Japanese site, patient and patient's legal representative must provide written informed consent before any study-specific tests or procedures are performed\n* Patient is eligible for percutaneous coronary intervention (PCI)\n* Patient has documented stable angina pectoris or documented silent ischemia; or unstable angina pectoris\n* Patient is an acceptable candidate for coronary artery bypass grafting (CABG)\n* Patient has a left ventricular ejection fraction (LVEF) \\>=30% as measured within 30 days prior to enrollment\n* Patient is willing to comply with all protocol-required follow-up evaluations\n\nAngiographic Inclusion Criteria (visual estimate):\n\n\\- Target lesion must be a de novo lesion \\>24 mm and ≤34 mm in length (by visual estimate) in a native coronary artery ≥2.50 mm to ≤4.25 mm in diameter (by visual estimate). Target lesion must be in a major coronary artery or branch with visually estimated stenosis \\>=50% and \\<100% with Thrombolysis in Myocardial Infarction (TIMI) flow \\>1.\n\nExclusion Criteria:\n\n* Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI\n* Patient has had a known diagnosis of recent MI (ie, within 72 hours prior to index procedure) and has elevated enzymes at time of index procedure as follows.\n\n * Patients are excluded if any of the following criteria are met at time of the index procedure.\n\n * If CK-MB \\>2× upper limit of normal (ULN), the patient is excluded regardless of CK Total.\n * If CK-MB is 1-2× ULN, the patient is excluded if the CK Total is \\>2× ULN.\n * If CK Total/CK MB are not used and Troponin is, patients are excluded if the following criterion is met at time of index procedure.\n\n * Troponin \\>1× ULN with at least one of the following.\n * Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (eg, \\>1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block \\[LBBB\\]);\n * Development of pathological Q waves in the ECG; or\n * Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.\n\nNote: For patients with unstable angina or patients who have had a recent MI, CK Total/CK MB (or Troponin if CK Total/CK MB are not used) must be documented prior to enrolling/randomizing the patient.\n\n* Patient has received an organ transplant or is on a waiting list for an organ transplant\n* Patient is receiving or scheduled to receive chemotherapy within 30 days before or after index procedure\n* Patient is receiving oral or intravenous immunosuppressive therapy (ie, inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (eg, human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)\n* Patient is receiving chronic (\\>=72 hours) anticoagulation therapy (eg, heparin, coumadin) for indications other than acute coronary syndrome\n* Patient has platelet count \\<100,000 cells/mm3 or \\>700,000 cells/mm3\n* Patient has white blood cell (WBC) count \\<3,000 cells/mm3\n* Patient has documented or suspected liver disease, including laboratory evidence of hepatitis\n* Patient is on dialysis or has known renal insufficiency (ie, estimated creatinine clearance \\<50 ml/min by the Cockcroft Gault formula, or \\[(140-age)\\*lean body weight (in kg)\\]/\\[plasma creatinine (mg/dl)\\*72\\])\n* Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions\n* Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol\n* Target vessel(s) or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to index procedure\n* Target vessel(s) has been treated within 10 mm proximal or distal to target lesion (by visual estimate) with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to index procedure\n* Non-target vessel or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to index procedure\n* Planned or actual target vessel(s) treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter immediately prior to stent placement\n* Planned PCI or CABG after index procedure\n* Patient previously treated at any time with coronary intravascular brachytherapy\n* Patient has a known allergy to the study stent system or protocol-required concomitant medications (eg, stainless steel, platinum, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated\n* Patient has active peptic ulcer or active gastrointestinal (GI) bleeding\n* Patient has one of the following.\n\n * Other serious medical illness (eg, cancer, congestive heart failure) that may reduce life expectancy to less than 24 months\n * Current problems with substance abuse (eg, alcohol, cocaine, heroin, etc.)\n * Planned procedure that may cause non-compliance with protocol or confound data interpretation\n* Patient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint\n* Patient intends to participate in another investigational drug or device clinical trial within 12 months after index procedure\n* Patient with known intention to procreate within 12 months after index procedure (Women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.)\n* Patient is a woman who is pregnant or nursing (A pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)\n* Patient has more than 2 target lesions, or more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure\n\nAngiographic Exclusion Criteria (visual estimate):\n\n* Target lesion meets any of the following criteria:\n\n * Aorto-ostial location (ie, lesion located within 5 mm of ostium by visual estimate)\n * Left main location\n * Located within 5 mm of origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate\n * Located within a saphenous vein graft or arterial graft\n * Will be accessed via a saphenous vein graft or arterial graft\n * Involves a side branch \\>=2.0 mm in diameter by visual estimate\n * Involves a clinically significant side branch \\<2.0 mm in diameter by visual estimate that has a clinically significant stenosis at the ostium\n * TIMI flow 0 (total occlusion) or TIMI flow 1 prior to wire crossing\n * Excessive tortuosity proximal to or within the lesion\n * Extreme angulation proximal to or within the lesion\n * Target lesion and/or target vessel proximal to the target lesion is moderately to severely calcified by visual estimate\n * Restenotic from previous intervention\n * Thrombus, or possible thrombus, present in target vessel\n* Non-target lesion to be treated during the index procedure meets any of the following criteria:\n\n * Located within the target vessel\n * Located within a bypass graft (venous or arterial)\n * Left main location\n * Chronic total occlusion\n * Involves a complex bifurcation (eg, bifurcations requiring treatment with more than 1 stent)\n * Restenotic from previous intervention\n* Patient has unprotected left main coronary artery disease (\\>50% diameter stenosis)\n* Patient has protected left main coronary artery disease and a target lesion in the LAD or LCX\n* Patient has an additional clinically significant lesion(s) in target vessel for which an intervention within 12 months after the index procedure is likely to be required\n* Patient has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate) Note: Multiple focal stenoses will be considered as a single lesion if they can be completely covered with 1 stent."}, 'identificationModule': {'nctId': 'NCT01500434', 'acronym': 'PLATINUM LL', 'briefTitle': 'The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of Long De Novo Coronary Artery Lesions (PLATINUM LL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions - Long Lesion Sub-trial', 'orgStudyIdInfo': {'id': 'S2046C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PROMUS Element', 'description': 'Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent', 'interventionNames': ['Device: PROMUS Element Coronary Stent System', 'Drug: Aspirin', 'Drug: Thienopyridine']}], 'interventions': [{'name': 'PROMUS Element Coronary Stent System', 'type': 'DEVICE', 'description': 'PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).', 'armGroupLabels': ['PROMUS Element']}, {'name': 'Aspirin', 'type': 'DRUG', 'description': 'Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.', 'armGroupLabels': ['PROMUS Element']}, {'name': 'Thienopyridine', 'type': 'DRUG', 'otherNames': ['A brand name for clopidogrel is PLAVIX.', 'A brand name for ticlopidine is TICLID.'], 'description': 'Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.', 'armGroupLabels': ['PROMUS Element']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Mercy General Hospital', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Alvarado Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'MediQuest Research Group Inc. at Munroe Regional Medical Center', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '49770', 'city': 'Petoskey', 'state': 'Michigan', 'country': 'United States', 'facility': 'Northern Michigan Hospital', 'geoPoint': {'lat': 45.37334, 'lon': -84.95533}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Abbott Northwestern Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'North Mississippi Medical Center', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Moses H. 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