Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT00004732
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2000-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Carotid Revascularization Endarterectomy Versus Stenting Trial
Sponsor:
Organization:
Raw JSON
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Brott, MD - Principal Investigator', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Periprocedural period', 'eventGroups': [{'id': 'EG000', 'title': 'Carotid-Artery Stenting', 'description': 'Patients Randomized to CAS', 'otherNumAtRisk': 1262, 'otherNumAffected': 213, 'seriousNumAtRisk': 1262, 'seriousNumAffected': 322}, {'id': 'EG001', 'title': 'Carotid Endarterectomy', 'description': 'Patients Randomized to CEA', 'otherNumAtRisk': 1240, 'otherNumAffected': 212, 'seriousNumAtRisk': 1240, 'seriousNumAffected': 292}], 'otherEvents': [{'term': 'Neurologic AE (non-endpoint, non-serious)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1262, 'numEvents': 81, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 83, 'numAffected': 72}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhagic/vascular AE (not serious)', 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{'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 42, 'numAffected': 36}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angiographic/Procedural AE (not serious)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1262, 'numEvents': 27, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 49, 'numAffected': 43}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other AE (not serious)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic/Electrolyte AE (not serious)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1262, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Miscellaneous Types of AEs (not serious)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1262, 'numEvents': 132, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 127, 'numAffected': 86}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurologic AE (endpoint, non-serious)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Neurologic SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1262, 'numEvents': 124, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 108, 'numAffected': 93}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhagic/Vascular SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1262, 'numEvents': 40, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 53, 'numAffected': 40}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemodynamic SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1262, 'numEvents': 80, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 63, 'numAffected': 56}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infectious Disorder SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1262, 'numEvents': 31, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1262, 'numEvents': 41, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 58, 'numAffected': 49}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angiographic/Procedural SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1262, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Miscellaneous SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1262, 'numEvents': 50, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 72, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic/Electrolyte SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1262, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1262', 'groupId': 'OG000'}, {'value': '1240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carotid-Artery Stenting', 'description': 'Patients Randomized to CAS'}, {'id': 'OG001', 'title': 'Carotid Endarterectomy', 'description': 'Patients Randomized to CEA'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.51', 'estimateComment': 'HR (95% CI) adjusted for age, sex and symptomatic status', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '30 days and 4 years', 'description': 'The primary aim of CREST is to assess if the efficacy of CAS differs from that of CEA in preventing stroke, myocardial infarction and death during a 30-day peri-procedural period, or ipsilateral stroke over the follow-up period in patients with symptomatic (\\>=50%) or asymptomatic (\\>=60%) extracranial carotid stenosis. Four-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Differential Efficacy of CAS and CEA in Male and Female Participants in the Primary Endpoint (Any Periprocedural Stroke, Myocardial Infarction, or Death or Postprocedural Ipsilateral Stroke).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1262', 'groupId': 'OG000'}, {'value': '1240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carotid-Artery Stenting', 'description': 'Patients randomized to CAS'}, {'id': 'OG001', 'title': 'Carotid Endarterectomy', 'description': 'Patients randomized to CEA'}], 'classes': [{'title': 'Men', 'categories': [{'measurements': [{'value': '6.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Women', 'categories': [{'measurements': [{'value': '8.9', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '0.82', 'ciUpperLimit': '2.23', 'estimateComment': 'HR (95% CI) for WOMEN CAS vs CEA (adjusted for age and symptomatic status)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '4 years', 'description': '4-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Carotid-Artery Stenting (CAS)', 'description': 'CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. The stent is then placed to cover the plaque and hold the artery open.'}, {'id': 'FG001', 'title': 'Carotid Endarterectomy (CEA)', 'description': 'CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1262'}, {'groupId': 'FG001', 'numSubjects': '1240'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1193'}, {'groupId': 'FG001', 'numSubjects': '1129'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '111'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '47'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1262', 'groupId': 'BG000'}, {'value': '1240', 'groupId': 'BG001'}, {'value': '2502', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Carotid-Artery Stenting', 'description': 'Patients Randomized to CAS'}, {'id': 'BG001', 'title': 'Carotid Endarterectomy', 'description': 'Patients Randomized to CEA'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.9', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '69.2', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '69.0', 'spread': '8.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '455', 'groupId': 'BG000'}, {'value': '417', 'groupId': 'BG001'}, {'value': '872', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '807', 'groupId': 'BG000'}, {'value': '823', 'groupId': 'BG001'}, {'value': '1630', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '1172', 'groupId': 'BG000'}, {'value': '1160', 'groupId': 'BG001'}, {'value': '2332', 'groupId': 'BG002'}]}]}, {'title': 'Non-White', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}, {'title': 'Not Specified', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Symptomatic Status', 'classes': [{'title': 'Asymptomatic', 'categories': [{'measurements': [{'value': '594', 'groupId': 'BG000'}, {'value': '587', 'groupId': 'BG001'}, {'value': '1181', 'groupId': 'BG002'}]}]}, {'title': 'Symptomatic', 'categories': [{'measurements': [{'value': '668', 'groupId': 'BG000'}, {'value': '653', 'groupId': 'BG001'}, {'value': '1321', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Hypertension', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '1080', 'groupId': 'BG000'}, {'value': '1061', 'groupId': 'BG001'}, {'value': '2141', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes Status', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '384', 'groupId': 'BG000'}, {'value': '375', 'groupId': 'BG001'}, {'value': '759', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '873', 'groupId': 'BG000'}, {'value': '857', 'groupId': 'BG001'}, {'value': '1730', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Dyslipidemia', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '1040', 'groupId': 'BG000'}, {'value': '1053', 'groupId': 'BG001'}, {'value': '2093', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Present Smoker', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '329', 'groupId': 'BG000'}, {'value': '317', 'groupId': 'BG001'}, {'value': '646', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '915', 'groupId': 'BG000'}, {'value': '899', 'groupId': 'BG001'}, {'value': '1814', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participant'}, {'title': 'Lesion Location', 'classes': [{'title': 'Left', 'categories': [{'measurements': [{'value': '639', 'groupId': 'BG000'}, {'value': '648', 'groupId': 'BG001'}, {'value': '1287', 'groupId': 'BG002'}]}]}, {'title': 'Right', 'categories': [{'measurements': [{'value': '623', 'groupId': 'BG000'}, {'value': '592', 'groupId': 'BG001'}, {'value': '1215', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '141.6', 'spread': '20.2', 'groupId': 'BG000'}, {'value': '141.2', 'spread': '20.5', 'groupId': 'BG001'}, {'value': '141.4', 'spread': '20.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '74.0', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '73.9', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '74.0', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percent Stenosis at Randomization', 'classes': [{'title': 'Moderate (<70%)', 'categories': [{'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}]}, {'title': 'Severe (>=70%)', 'categories': [{'measurements': [{'value': '1097', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2151', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2502}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-13', 'studyFirstSubmitDate': '2000-02-25', 'resultsFirstSubmitDate': '2013-09-26', 'studyFirstSubmitQcDate': '2000-02-25', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-09-26', 'studyFirstPostDateStruct': {'date': '2000-02-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years.', 'timeFrame': '30 days and 4 years', 'description': 'The primary aim of CREST is to assess if the efficacy of CAS differs from that of CEA in preventing stroke, myocardial infarction and death during a 30-day peri-procedural period, or ipsilateral stroke over the follow-up period in patients with symptomatic (\\>=50%) or asymptomatic (\\>=60%) extracranial carotid stenosis. Four-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.'}], 'secondaryOutcomes': [{'measure': 'Differential Efficacy of CAS and CEA in Male and Female Participants in the Primary Endpoint (Any Periprocedural Stroke, Myocardial Infarction, or Death or Postprocedural Ipsilateral Stroke).', 'timeFrame': '4 years', 'description': '4-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['angioplasty', 'asymptomatic', 'atherosclerosis', 'carotid endarterectomy', 'carotid stenting', 'CREST', 'Cerebral Infarction', 'device', 'intervention', 'restenosis', 'revascularization', 'stenosis', 'stent', 'stroke', 'symptomatic', 'surgery', 'transient ischemic attack'], 'conditions': ['Atherosclerosis', 'Stroke', 'Carotid Stenosis', 'Cerebral Infarction', 'Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '20189092', 'type': 'BACKGROUND', 'citation': 'Hopkins LN, Roubin GS, Chakhtoura EY, Gray WA, Ferguson RD, Katzen BT, Rosenfield K, Goldstein J, Cutlip DE, Morrish W, Lal BK, Sheffet AJ, Tom M, Hughes S, Voeks J, Kathir K, Meschia JF, Hobson RW 2nd, Brott TG. The Carotid Revascularization Endarterectomy versus Stenting Trial: credentialing of interventionalists and final results of lead-in phase. J Stroke Cerebrovasc Dis. 2010 Mar;19(2):153-62. doi: 10.1016/j.jstrokecerebrovasdis.2010.01.001.'}, {'pmid': '19211486', 'type': 'BACKGROUND', 'citation': 'Howard VJ, Voeks JH, Lutsep HL, Mackey A, Milot G, Sam AD 2nd, Tom M, Hughes SE, Sheffet AJ, Longbottom M, Avery JB, Hobson RW 2nd, Brott TG. Does sex matter? Thirty-day stroke and death rates after carotid artery stenting in women versus men: results from the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) lead-in phase. Stroke. 2009 Apr;40(4):1140-7. doi: 10.1161/STROKEAHA.108.541847. Epub 2009 Feb 10.'}, {'pmid': '20088993', 'type': 'BACKGROUND', 'citation': 'Sheffet AJ, Roubin G, Howard G, Howard V, Moore W, Meschia JF, Hobson RW 2nd, Brott TG. Design of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST). Int J Stroke. 2010 Feb;5(1):40-6. doi: 10.1111/j.1747-4949.2009.00405.x.'}, {'pmid': '19878793', 'type': 'BACKGROUND', 'citation': 'Lal BK, Brott TG. The Carotid Revascularization Endarterectomy vs. Stenting Trial completes randomization: lessons learned and anticipated results. J Vasc Surg. 2009 Nov;50(5):1224-31. doi: 10.1016/j.jvs.2009.09.003.'}, {'pmid': '15860747', 'type': 'BACKGROUND', 'citation': 'Hobson RW 2nd, Brott TG, Roubin GS, Silver FL, Barnett HJ. Carotid artery stenting: meeting the recruitment challenge of a clinical trial. Stroke. 2005 Jun;36(6):1314-5. doi: 10.1161/01.STR.0000165919.26944.05. Epub 2005 Apr 28. No abstract available.'}, {'pmid': '15622363', 'type': 'BACKGROUND', 'citation': 'Hobson RW 2nd, Howard VJ, Roubin GS, Brott TG, Ferguson RD, Popma JJ, Graham DL, Howard G; CREST Investigators. Carotid artery stenting is associated with increased complications in octogenarians: 30-day stroke and death rates in the CREST lead-in phase. J Vasc Surg. 2004 Dec;40(6):1106-11. doi: 10.1016/j.jvs.2004.10.022.'}, {'pmid': '15557910', 'type': 'BACKGROUND', 'citation': 'Hobson RW 2nd, Howard VJ, Roubin GS, Ferguson RD, Brott TG, Howard G, Sheffet AJ, Roberts J, Hopkins LN, Moore WS; CREST. Credentialing of surgeons as interventionalists for carotid artery stenting: experience from the lead-in phase of CREST. J Vasc Surg. 2004 Nov;40(5):952-7. doi: 10.1016/j.jvs.2004.08.039.'}, {'pmid': '11806790', 'type': 'BACKGROUND', 'citation': 'Hobson RW 2nd, Howard VJ, Brott TG, Howard G, Roubin GS, Ferguson RD; For the CREST Executive Committee. Organizing the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST): National Institutes of Health, Health Care Financing Administration, and industry funding. Curr Control Trials Cardiovasc Med. 2001 Jul 13;2(4):160-164. doi: 10.1186/cvm-2-4-160.'}, {'pmid': '9464598', 'type': 'BACKGROUND', 'citation': 'Hobson RW 2nd, Brott T, Ferguson R, Roubin G, Moore W, Kuntz R, Howard G, Ferguson J. CREST: carotid revascularization endarterectomy versus stent trial. Cardiovasc Surg. 1997 Oct;5(5):457-8. doi: 10.1016/s0967-2109(97)00048-3. No abstract available.'}, {'pmid': '20505173', 'type': 'RESULT', 'citation': 'Brott TG, Hobson RW 2nd, Howard G, Roubin GS, Clark WM, Brooks W, Mackey A, Hill MD, Leimgruber PP, Sheffet AJ, Howard VJ, Moore WS, Voeks JH, Hopkins LN, Cutlip DE, Cohen DJ, Popma JJ, Ferguson RD, Cohen SN, Blackshear JL, Silver FL, Mohr JP, Lal BK, Meschia JF; CREST Investigators. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med. 2010 Jul 1;363(1):11-23. doi: 10.1056/NEJMoa0912321. Epub 2010 May 26.'}, {'pmid': '20876500', 'type': 'RESULT', 'citation': 'Mantese VA, Timaran CH, Chiu D, Begg RJ, Brott TG; CREST Investigators. The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST): stenting versus carotid endarterectomy for carotid disease. Stroke. 2010 Oct;41(10 Suppl):S31-4. doi: 10.1161/STROKEAHA.110.595330.'}, {'pmid': '21307169', 'type': 'RESULT', 'citation': 'Silver FL, Mackey A, Clark WM, Brooks W, Timaran CH, Chiu D, Goldstein LB, Meschia JF, Ferguson RD, Moore WS, Howard G, Brott TG; CREST Investigators. Safety of stenting and endarterectomy by symptomatic status in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke. 2011 Mar;42(3):675-80. doi: 10.1161/STROKEAHA.110.610212. Epub 2011 Feb 9.'}, {'pmid': '21606394', 'type': 'RESULT', 'citation': 'Blackshear JL, Cutlip DE, Roubin GS, Hill MD, Leimgruber PP, Begg RJ, Cohen DJ, Eidt JF, Narins CR, Prineas RJ, Glasser SP, Voeks JH, Brott TG; CREST Investigators. Myocardial infarction after carotid stenting and endarterectomy: results from the carotid revascularization endarterectomy versus stenting trial. Circulation. 2011 Jun 7;123(22):2571-8. doi: 10.1161/CIRCULATIONAHA.110.008250. Epub 2011 May 23.'}, {'pmid': '22821614', 'type': 'RESULT', 'citation': 'Vilain KR, Magnuson EA, Li H, Clark WM, Begg RJ, Sam AD 2nd, Sternbergh WC 3rd, Weaver FA, Gray WA, Voeks JH, Brott TG, Cohen DJ; CREST Investigators. Costs and cost-effectiveness of carotid stenting versus endarterectomy for patients at standard surgical risk: results from the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke. 2012 Sep;43(9):2408-16. doi: 10.1161/STROKEAHA.112.661355. Epub 2012 Jul 19.'}, {'pmid': '22857850', 'type': 'RESULT', 'citation': 'Lal BK, Beach KW, Roubin GS, Lutsep HL, Moore WS, Malas MB, Chiu D, Gonzales NR, Burke JL, Rinaldi M, Elmore JR, Weaver FA, Narins CR, Foster M, Hodgson KJ, Shepard AD, Meschia JF, Bergelin RO, Voeks JH, Howard G, Brott TG; CREST Investigators. Restenosis after carotid artery stenting and endarterectomy: a secondary analysis of CREST, a randomised controlled trial. Lancet Neurol. 2012 Sep;11(9):755-63. doi: 10.1016/S1474-4422(12)70159-X. Epub 2012 Aug 2.'}, {'pmid': '23159552', 'type': 'RESULT', 'citation': 'Hill MD, Brooks W, Mackey A, Clark WM, Meschia JF, Morrish WF, Mohr JP, Rhodes JD, Popma JJ, Lal BK, Longbottom ME, Voeks JH, Howard G, Brott TG; CREST Investigators. Stroke after carotid stenting and endarterectomy in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST). Circulation. 2012 Dec 18;126(25):3054-61. doi: 10.1161/CIRCULATIONAHA.112.120030. Epub 2012 Nov 16.'}, {'pmid': '23265585', 'type': 'RESULT', 'citation': 'Timaran CH, Mantese VA, Malas M, Brown OW, Lal BK, Moore WS, Voeks JH, Brott TG; CREST Investigators. Differential outcomes of carotid stenting and endarterectomy performed exclusively by vascular surgeons in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST). J Vasc Surg. 2013 Feb;57(2):303-8. doi: 10.1016/j.jvs.2012.09.014. Epub 2012 Dec 20.'}, {'pmid': '34695552', 'type': 'DERIVED', 'citation': 'Matsumura JS, Hanlon BM, Rosenfield K, Voeks JH, Howard G, Roubin GS, Brott TG. Treatment of carotid stenosis in asymptomatic, nonoctogenarian, standard risk patients with stenting versus endarterectomy trials. J Vasc Surg. 2022 Apr;75(4):1276-1283.e1. doi: 10.1016/j.jvs.2021.10.020. Epub 2021 Oct 22.'}, {'pmid': '33493046', 'type': 'DERIVED', 'citation': "Howard VJ, Algra A, Howard G, Bonati LH, de Borst GJ, Bulbulia R, Calvet D, Eckstein HH, Fraedrich G, Greving JP, Halliday A, Hendrikse J, Jansen O, Brown MM, Mas JL, Ringleb PA, Brott TG; Carotid Stenosis Trialists' Collaboration. Absence of Consistent Sex Differences in Outcomes From Symptomatic Carotid Endarterectomy and Stenting Randomized Trials. Stroke. 2021 Jan;52(2):416-423. doi: 10.1161/STROKEAHA.120.030184. Epub 2021 Jan 25."}, {'pmid': '31378071', 'type': 'DERIVED', 'citation': 'Muller MD, von Felten S, Algra A, Becquemin JP, Bulbulia R, Calvet D, Eckstein HH, Fraedrich G, Halliday A, Hendrikse J, Howard G, Gregson J, Jansen O, Brown MM, Mas JL, Brott TG, Ringleb PA, Bonati LH. Secular Trends in Procedural Stroke or Death Risks of Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis. Circ Cardiovasc Interv. 2019 Aug;12(8):e007870. doi: 10.1161/CIRCINTERVENTIONS.119.007870. Epub 2019 Aug 5.'}, {'pmid': '30630649', 'type': 'DERIVED', 'citation': 'Moore WS, Voeks JH, Roubin GS, Clark WM, Howard VJ, Jones MR, Brott TG; CREST Investigators. Duration of asymptomatic status and outcomes following carotid endarterectomy and carotid artery stenting in the Carotid Revascularization Endarterectomy vs Stenting Trial. J Vasc Surg. 2019 Jun;69(6):1797-1800. doi: 10.1016/j.jvs.2018.09.054. Epub 2019 Jan 8.'}, {'pmid': '30571337', 'type': 'DERIVED', 'citation': 'Jones MR, Howard G, Roubin GS, Blackshear JL, Cohen DJ, Cutlip DE, Leimgruber PP, Rhodes D, Prineas RJ, Glasser SP, Lal BK, Voeks JH, Brott TG; CREST Investigators. Periprocedural Stroke and Myocardial Infarction as Risks for Long-Term Mortality in CREST. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e004663. doi: 10.1161/CIRCOUTCOMES.117.004663.'}, {'pmid': '30527940', 'type': 'DERIVED', 'citation': 'Lal BK, Roubin GS, Jones M, Clark W, Mackey A, Hill MD, Voeks JH, Howard G, Hobson RW 2nd, Brott TG. Influence of multiple stents on periprocedural stroke after carotid artery stenting in the Carotid Revascularization Endarterectomy versus Stent Trial (CREST). J Vasc Surg. 2019 Mar;69(3):800-806. doi: 10.1016/j.jvs.2018.06.221. Epub 2018 Dec 4.'}, {'pmid': '30355202', 'type': 'DERIVED', 'citation': "Muller MD, von Felten S, Algra A, Becquemin JP, Brown M, Bulbulia R, Calvet D, Eckstein HH, Fraedrich G, Halliday A, Hendrikse J, Gregson J, Howard G, Jansen O, Mas JL, Brott TG, Ringleb PA, Bonati LH; Carotid Stenosis Trialists' Collaboration. Immediate and Delayed Procedural Stroke or Death in Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis. Stroke. 2018 Nov;49(11):2715-2722. doi: 10.1161/STROKEAHA.118.020684."}, {'pmid': '29191852', 'type': 'DERIVED', 'citation': 'Sheffet AJ, Howard G, Sam A, Jamil Z, Weaver F, Chiu D, Voeks JH, Howard VJ, Hughes SE, Flaxman L, Longbottom ME, Brott TG; CREST Investigators. Challenge and Yield of Enrolling Racially and Ethnically Diverse Patient Populations in Low Event Rate Clinical Trials. Stroke. 2018 Jan;49(1):84-89. doi: 10.1161/STROKEAHA.117.018063. Epub 2017 Nov 30.'}, {'pmid': '28455318', 'type': 'DERIVED', 'citation': "Rantner B, Kollerits B, Roubin GS, Ringleb PA, Jansen O, Howard G, Hendrikse J, Halliday A, Gregson J, Eckstein HH, Calvet D, Bulbulia R, Bonati LH, Becquemin JP, Algra A, Brown MM, Mas JL, Brott TG, Fraedrich G; Carotid Stenosis Trialists' Collaboration. Early Endarterectomy Carries a Lower Procedural Risk Than Early Stenting in Patients With Symptomatic Stenosis of the Internal Carotid Artery: Results From 4 Randomized Controlled Trials. Stroke. 2017 Jun;48(6):1580-1587. doi: 10.1161/STROKEAHA.116.016233. Epub 2017 Apr 28."}, {'pmid': '26890472', 'type': 'DERIVED', 'citation': 'Brott TG, Howard G, Roubin GS, Meschia JF, Mackey A, Brooks W, Moore WS, Hill MD, Mantese VA, Clark WM, Timaran CH, Heck D, Leimgruber PP, Sheffet AJ, Howard VJ, Chaturvedi S, Lal BK, Voeks JH, Hobson RW 2nd; CREST Investigators. Long-Term Results of Stenting versus Endarterectomy for Carotid-Artery Stenosis. N Engl J Med. 2016 Mar 17;374(11):1021-31. doi: 10.1056/NEJMoa1505215. Epub 2016 Feb 18.'}, {'pmid': '26610643', 'type': 'DERIVED', 'citation': 'Moore WS, Popma JJ, Roubin GS, Voeks JH, Cutlip DE, Jones M, Howard G, Brott TG; CREST Investigators. Carotid angiographic characteristics in the CREST trial were major contributors to periprocedural stroke and death differences between carotid artery stenting and carotid endarterectomy. J Vasc Surg. 2016 Apr;63(4):851-7, 858.e1. doi: 10.1016/j.jvs.2015.08.119. Epub 2015 Nov 21.'}, {'pmid': '26493675', 'type': 'DERIVED', 'citation': 'Meschia JF, Hopkins LN, Altafullah I, Wechsler LR, Stotts G, Gonzales NR, Voeks JH, Howard G, Brott TG. Time From Symptoms to Carotid Endarterectomy or Stenting and Perioperative Risk. Stroke. 2015 Dec;46(12):3540-2. doi: 10.1161/STROKEAHA.115.011123. Epub 2015 Oct 22.'}, {'pmid': '26351359', 'type': 'DERIVED', 'citation': 'Voeks JH, Howard G, Roubin G, Farb R, Heck D, Logan W, Longbottom M, Sheffet A, Meschia JF, Brott TG. Mediators of the Age Effect in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke. 2015 Oct;46(10):2868-73. doi: 10.1161/STROKEAHA.115.009516. Epub 2015 Sep 8.'}, {'pmid': '26173731', 'type': 'DERIVED', 'citation': 'Howard G, Hopkins LN, Moore WS, Katzen BT, Chakhtoura E, Morrish WF, Ferguson RD, Hye RJ, Shawl FA, Harrigan MR, Voeks JH, Howard VJ, Lal BK, Meschia JF, Brott TG. Temporal Changes in Periprocedural Events in the Carotid Revascularization Endarterectomy Versus Stenting Trial. Stroke. 2015 Aug;46(8):2183-9. doi: 10.1161/STROKEAHA.115.008898. Epub 2015 Jul 14.'}, {'pmid': '26122922', 'type': 'DERIVED', 'citation': 'Sheffet AJ, Voeks JH, Mackey A, Brooks W, Clark WM, Hill MD, Howard VJ, Hughes SE, Tom M, Longbottom ME, Brott TG; CREST Investigators. Characteristics of participants consenting versus declining follow-up for up to 10 years in a randomized clinical trial. Clin Trials. 2015 Dec;12(6):657-63. doi: 10.1177/1740774515590807. Epub 2015 Jun 29.'}, {'pmid': '25613307', 'type': 'DERIVED', 'citation': 'Malas M, Glebova NO, Hughes SE, Voeks JH, Qazi U, Moore WS, Lal BK, Howard G, Llinas R, Brott TG. Effect of patching on reducing restenosis in the carotid revascularization endarterectomy versus stenting trial. Stroke. 2015 Mar;46(3):757-61. doi: 10.1161/STROKEAHA.114.007634. Epub 2015 Jan 22.'}, {'pmid': '25428209', 'type': 'DERIVED', 'citation': 'Meschia JF, Voeks JH, Leimgruber PP, Mantese VA, Timaran CH, Chiu D, Demaerschalk BM, Howard VJ, Hughes SE, Longbottom M, Howard AG, Brott TG. Management of vascular risk factors in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). J Am Heart Assoc. 2014 Nov 26;3(6):e001180. doi: 10.1161/JAHA.114.001180.'}, {'pmid': '25256180', 'type': 'DERIVED', 'citation': 'Gonzales NR, Demaerschalk BM, Voeks JH, Tom M, Howard G, Sheffet AJ, Garcia L, Clair DG, Barr J, Orlow S, Brott TG; CREST Investigators. Complication rates and center enrollment volume in the carotid revascularization endarterectomy versus stenting trial. Stroke. 2014 Nov;45(11):3320-4. doi: 10.1161/STROKEAHA.114.006228. Epub 2014 Sep 25.'}, {'pmid': '25213339', 'type': 'DERIVED', 'citation': 'Howard G, Voeks JH, Meschia JF, Howard VJ, Brott TG. Picking the good apples: statistics versus good judgment in choosing stent operators for a multicenter clinical trial. Stroke. 2014 Nov;45(11):3325-9. doi: 10.1161/STROKEAHA.114.006807. Epub 2014 Sep 11.'}, {'pmid': '24661748', 'type': 'DERIVED', 'citation': 'Sheffet AJ, Flaxman L, Tom M, Hughes SE, Longbottom ME, Howard VJ, Marler JR, Brott TG; CREST Investigators. Financial management of a large multisite randomized clinical trial. Int J Stroke. 2014 Aug;9(6):811-3. doi: 10.1111/ijs.12259. Epub 2014 Mar 24.'}, {'pmid': '24055515', 'type': 'DERIVED', 'citation': 'Zierler RE, Beach KW, Bergelin RO, Lal BK, Moore WS, Roubin GS, Voeks JH, Brott TG; CREST Investigators. Agreement between site-reported and ultrasound core laboratory results for duplex ultrasound velocity measurements in the Carotid Revascularization Endarterectomy versus Stenting Trial. J Vasc Surg. 2014 Jan;59(1):2-7. doi: 10.1016/j.jvs.2013.06.071. Epub 2013 Sep 19.'}, {'pmid': '22941123', 'type': 'DERIVED', 'citation': 'Habersberger J, Brott TG, Roubin GS. Carotid artery stenting: a clinical update. Curr Opin Cardiol. 2012 Nov;27(6):565-71. doi: 10.1097/HCO.0b013e3283587506.'}, {'pmid': '21980205', 'type': 'DERIVED', 'citation': 'Voeks JH, Howard G, Roubin GS, Malas MB, Cohen DJ, Sternbergh WC 3rd, Aronow HD, Eskandari MK, Sheffet AJ, Lal BK, Meschia JF, Brott TG; CREST Investigators. Age and outcomes after carotid stenting and endarterectomy: the carotid revascularization endarterectomy versus stenting trial. Stroke. 2011 Dec;42(12):3484-90. doi: 10.1161/STROKEAHA.111.624155. Epub 2011 Oct 6.'}, {'pmid': '21958882', 'type': 'DERIVED', 'citation': 'Cohen DJ, Stolker JM, Wang K, Magnuson EA, Clark WM, Demaerschalk BM, Sam AD Jr, Elmore JR, Weaver FA, Aronow HD, Goldstein LB, Roubin GS, Howard G, Brott TG; CREST Investigators. Health-related quality of life after carotid stenting versus carotid endarterectomy: results from CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial). J Am Coll Cardiol. 2011 Oct 4;58(15):1557-65. doi: 10.1016/j.jacc.2011.05.054.'}, {'pmid': '21899409', 'type': 'DERIVED', 'citation': 'Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003. doi: 10.1056/NEJMoa1105335. Epub 2011 Sep 7.'}, {'pmid': '21550314', 'type': 'DERIVED', 'citation': 'Howard VJ, Lutsep HL, Mackey A, Demaerschalk BM, Sam AD 2nd, Gonzales NR, Sheffet AJ, Voeks JH, Meschia JF, Brott TG; CREST investigators. Influence of sex on outcomes of stenting versus endarterectomy: a subgroup analysis of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST). Lancet Neurol. 2011 Jun;10(6):530-7. doi: 10.1016/S1474-4422(11)70080-1. Epub 2011 May 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to compare the relatively new procedure of stent-assisted carotid angioplasty (CAS) to the traditional and accepted surgical approach of carotid endarterectomy (CEA) for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in those patients who have not had any symptoms within the past 6 months (asymptomatic).', 'detailedDescription': 'The primary aim of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to contrast the relative effectiveness of carotid artery stenting (CAS) versus carotid endarterectomy (CEA) in preventing stroke, myocardial infarction, and death. Stents are medical devices approved and commonly used for treatment of heart disease. The stent that will be used in this trial is the Rapid Exchange(RX) ACCULINK(TM) Carotid Stent System, an elastic-like metal scaffold that is expanded inside a carotid artery to hold the vessel open.\n\nThe RX ACCUNET(TM) Embolic Protection System (an umbrella-like device that expands above the narrowed portion of the carotid artery) will be used in conjunction with the RX ACCULINK stent. The RX ACCUNET system is designed to capture embolic material that could break off from the narrowed area in the carotid artery while still allowing blood to flow through the vessel during the procedure. Embolic material could block blood flow to the arteries beyond the narrowing and be harmful to the brain. The RX ACCUNET System is closed and removed after the stent is placed.\n\nCEA involves a neck incision and physical removal of the plaque from the inside of the artery. CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. The stent is then placed to cover the plaque and hold the artery open. Participants will be randomly assigned to undergo either CAS or CEA, and all patients will receive best medical management, which includes treatment with aspirin, treatment of high blood pressure, and treatment of other stroke risk factors. Participants will be followed for up to ten years.\n\nWith the simplification of the protocol for long-term follow-up, the focus for secondary outcomes is to assess restenosis and viability of the procedure. Restenosis rates on an annual basis in both the endarterectomy and stenting arms of the study will be assessed using carotid duplex ultrasound exams performed annually (standard of care).\n\nIn addition to restenosis, the "viability" of the procedures will be assessed by the need (or lack of need) for repeat revascularization (either open surgical or endovascular) after the index procedure. The question "has a new carotid intervention been performed since last follow-up" will be asked at every contact with the patient. If answered positively, additional data will be collected on the appropriate case report forms(CRFs).\n\nLINKAGE OF CREST COHORT WITH CENTERS FOR MEDICAID AND MEDICARE SERVICES(CMS) ADMINISTRATIVE DATA\n\nThe purpose of linking Medicare-eligible CREST participants with CMS data files is to assess patient outcomes and utilization of health care services. This plan to link in- and out-patient episodes of care using national Medicare data establishes a new resource that will enhance current follow-up strategies, as well as explore alternative strategies to ascertain patient outcomes for future clinical studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic patients with recent neurological events (TIA or non-disabling stroke) with an associated carotid stenosis greater than or equal to 50% by angiography or greater than or equal to 70% by ultrasound or greater than or equal to 70% by Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA) are eligible for randomization.\n* Asymptomatic patients with no recent (in the last 6 months) neurological events referable to the study with artery and carotid stenosis (patients with symptoms beyond 180 days are considered asymptomatic) greater than or equal to 60% by angiography or greater than or equal to 70% by ultrasound or greater than or equal to 80% by CTA or MRA are eligible for randomization.\n\nExclusion Criteria:\n\n* Conditions that: (1) interfere with the evaluation of endpoints, (2) are known to interfere with the completion of CEA or CAS, or (3) affect the likelihood of survival for the study period (4 years). Chronic atrial fibrillation and/or anti-coagulation or episodic atrial fibrillation within the last 6 months.'}, 'identificationModule': {'nctId': 'NCT00004732', 'acronym': 'CREST', 'briefTitle': 'Carotid Revascularization Endarterectomy Versus Stenting Trial', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)', 'orgStudyIdInfo': {'id': '0119970017'}, 'secondaryIdInfos': [{'id': 'R01NS038384', 'link': 'https://reporter.nih.gov/quickSearch/R01NS038384', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Carotid Artery Endarterectomy (CEA)', 'description': 'Carotid endarterectomy is surgery to remove plaque buildup that causes narrowing (stenosis) in the carotid artery.', 'interventionNames': ['Procedure: Carotid Endarterectomy (CEA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carotid Artery Stenting (CAS)', 'description': 'Carotid artery stenting (CAS) is a procedure used to open narrowed carotid arteries. During the procedure, a small, expandable wire tube called a stent is permanently inserted into the carotid artery.', 'interventionNames': ['Device: Carotid Artery Stenting (CAS)']}], 'interventions': [{'name': 'Carotid Endarterectomy (CEA)', 'type': 'PROCEDURE', 'description': 'CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.', 'armGroupLabels': ['Carotid Artery Endarterectomy (CEA)']}, {'name': 'Carotid Artery Stenting (CAS)', 'type': 'DEVICE', 'otherNames': ['Angioplasty of carotid artery and stent placement.'], 'description': 'CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. A stent is then placed to cover the plaque and hold the artery open. Participants randomized to this arm of the trial were treated using the RX Acculink Carotid Stent with or without the RX Accunet Embolic Protection Device.', 'armGroupLabels': ['Carotid Artery Stenting (CAS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Dignity Health dba St. Joseph's Hospital & Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'The Arizona Board of 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