Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT00766493
Status:
COMPLETED
Last Update Posted:
2016-09-29
First Post:
2008-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'BRandall@WLGore.com', 'phone': '(800) 437-8181', 'title': 'Bryan Randall', 'organization': 'W. L. Gore & Associates'}, 'certainAgreement': {'otherDetails': 'Gore has the right to review disclosures, requesting a delay of less than 90 days. Each investigator will postpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating sites.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'EMBOLDEN', 'description': 'GORE® Embolic Filter with carotid artery stenting', 'otherNumAtRisk': 250, 'otherNumAffected': 83, 'seriousNumAtRisk': 250, 'seriousNumAffected': 56}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous System - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 39, 'numAffected': 38}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood & Lymphatic System - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina/coronary ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asystole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congestive Heart Failure (CHF) - onset or worsening of', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction (MI)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis/Occlusion - GEF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retroperitoneal bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Groin Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection at access site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolism & Nutrition - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal and Connective Tissue - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous System - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral ischemia/transient ischemic attack (TIA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke/cerebrovascular accident (CVA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal failure/insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal & Urinary - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, Thoracic & Mediastinal - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COPD, worsening of', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemia/Infarction of tissue/organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel dissection, perforation or rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Not Elsewhere Classified - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EMBOLDEN', 'description': 'GORE® Embolic Filter with carotid artery stenting'}], 'classes': [{'title': 'Subjects With One or More Major Adverse Events', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Myocardial Infarction (MI - Overall)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Q-Wave MI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Non-Q-Wave MI', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Stroke (Overall)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Major Stroke (Overall)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Ischemic Stroke (Major)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hemorrhagic Stroke (Major)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Minor Stroke (Overall)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Ischemic Stroke (Minor)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Hemorrhagic Stroke (Minor)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'paramType': 'Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.043', 'ciLowerLimit': '0.021', 'ciUpperLimit': '0.077', 'pValueComment': 'Reject H0 if z\\<-1.96, or 1-sided p\\<0.025.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.013', 'estimateComment': 'The 2-sided 95% CI is reported for descriptive purposes; the statistical hypothesis test is 1-sided.', 'groupDescription': 'This study is designed to test the primary null hypothesis that the composite MAE outcome of all death, stroke, and/or MI when using the GORE Embolic Filter is equal to or higher than a Performance Goal (PG) of 6.4% established from published carotid stenting studies utilizing distal embolic protection, versus the alternative hypothesis that the composite MAE outcome is less than the performance goal.\n\nThe sample size was calculated based on 80% power and a 1-sided Type I error rate of 0.025.', 'statisticalMethod': 'One Sample Binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Significance test was based on a one-sample normal approximation to the binomial test.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'EMBOLDEN subjects evaluable for the primary endpoint'}, {'type': 'SECONDARY', 'title': 'Device Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EMBOLDEN', 'description': 'GORE® Embolic Filter with carotid artery stenting'}], 'classes': [{'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post Procedure', 'description': 'Device Success defined as the number of participants with Technical Success using the GORE Embolic Protection System (i.e., the GORE Embolic Filter device was delivered, placed, and retrieved as outlined in the Instructions for Use).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EMBOLDEN', 'description': 'GORE® Embolic Filter with carotid artery stenting'}], 'classes': [{'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Clinical Success defined as GORE Embolic Filter and carotid stent success in the absence of death, emergency endarterectomy, repeat PTA / thrombolysis of the target vessel, and stroke or MI as determined by the Clinical Events Committee. Clinical success will be evaluated from procedure through 24-48 hours postprocedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Access Site Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EMBOLDEN', 'description': 'GORE® Embolic Filter with carotid artery stenting'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Access Site Complications defined as the presence of a large hematoma (\\>5cm or requiring treatment or prolonged hospitalization), fistula or pseudoaneurysm formation, retroperitoneal bleeding or the need for surgical repair postprocedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neurologic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EMBOLDEN', 'description': 'GORE® Embolic Filter with carotid artery stenting'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Neurological Events at 30 days post-procedure, including transient ischemic attacks (TIAs).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EMBOLDEN', 'description': 'GORE® Embolic Filter with carotid artery stenting'}], 'periods': [{'title': 'Pre-Discharge', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '30 Days Post-Procedure', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '238'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Missed Visit - Phone Contact f/u', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Missed Visit - No Phone Contact', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study will be conducted at a maximum of 40 medical institutions in the United States (including public and academic research center hospitals and private practices) and will enroll approximately 250 subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'EMBOLDEN', 'description': 'GORE® Embolic Filter with carotid artery stenting'}], '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': '206', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '74.7', 'spread': '9.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '74.7', 'groupId': 'BG000', 'lowerLimit': '51.3', 'upperLimit': '92.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '97', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '153', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of Diabetes', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '163', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'History of Hypertension', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '236', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'History of Ischemic Stroke', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}]}]}, {'title': 'One', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}, {'title': 'Two or More', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Endarterectomy', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}]}]}, {'title': 'Less than 1 Year', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': '1 Year or Greater', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Symptomatology', 'classes': [{'title': 'Symptomatic', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}, {'title': 'Asymptomatic', 'categories': [{'measurements': [{'value': '213', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-22', 'studyFirstSubmitDate': '2008-10-03', 'resultsFirstSubmitDate': '2012-06-28', 'studyFirstSubmitQcDate': '2008-10-03', 'lastUpdatePostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-28', 'studyFirstPostDateStruct': {'date': '2008-10-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Device Success', 'timeFrame': 'Post Procedure', 'description': 'Device Success defined as the number of participants with Technical Success using the GORE Embolic Protection System (i.e., the GORE Embolic Filter device was delivered, placed, and retrieved as outlined in the Instructions for Use).'}, {'measure': 'Clinical Success', 'timeFrame': '30 days', 'description': 'Clinical Success defined as GORE Embolic Filter and carotid stent success in the absence of death, emergency endarterectomy, repeat PTA / thrombolysis of the target vessel, and stroke or MI as determined by the Clinical Events Committee. Clinical success will be evaluated from procedure through 24-48 hours postprocedure.'}, {'measure': 'Access Site Complications', 'timeFrame': '30 days', 'description': 'Access Site Complications defined as the presence of a large hematoma (\\>5cm or requiring treatment or prolonged hospitalization), fistula or pseudoaneurysm formation, retroperitoneal bleeding or the need for surgical repair postprocedure.'}, {'measure': 'Neurologic Events', 'timeFrame': '30 days', 'description': 'Neurological Events at 30 days post-procedure, including transient ischemic attacks (TIAs).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['carotid artery stenosis', 'embolic protection device', 'distal embolic filter', 'minimizing risks of carotid artery stenting'], 'conditions': ['Carotid Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'Compare the 30-day safety and efficacy of the GORE® Embolic Filter used in conjunction with FDA-approved carotid stents to a performance goal obtained from carotid stent studies utilizing distal embolic protection.', 'detailedDescription': 'Continuous advances in angioplasty techniques and the development of low-profile, flexible, tapered nitinol stents designed specifically for carotid applications have made CAS a viable alternative to CEA. Advances in embolic protection technology will assist in moving CAS forward as a universally accepted procedure. While the GORE® Embolic Filter is similar in many ways to other currently available filters, it has been designed to provide optimal vessel wall apposition. Bench tests suggest that the wall apposition may provide improved filter efficiency, thereby minimizing embolization of particles downstream and potentially decreasing adverse clinical effects. In addition, preclinical testing suggests that the GORE® Embolic Filter has improved deliverability, including torque ability and lesion cross that may improve the ability of the system to access and treat tight lesions in tortuous anatomy. Thus, the purpose of this multi-center clinical study is to assess the safety and effectiveness of the GORE® Embolic Filter when used to provide cerebral embolic protection during carotid artery angioplasty and stenting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is either:\n\n * Symptomatic (amaurosis fugax in the hemisphere supplied by the target vessel, TIA or non-disabling stroke within 6 months of the procedure) with carotid stenosis ≥50% as diagnosed by angiography using NASCET methodology, OR\n * Asymptomatic with carotid stenosis ≥80% as diagnosed by angiography using NASCET methodology\n2. Target lesion is located in one of the following:\n\n * ICA\n * bifurcation\n * CCA proximal to the bifurcation\n3. At Anatomic risk for adverse events from CEA (e.g., restenosis after a prior CEA) or at Co-morbid risk for adverse events from CEA (e.g., unstable angina with ECG changes)\n\nExclusion Criteria:\n\n* Recent surgical procedure within 30 days before or after the stent procedure\n* Uncontrolled sensitivity to contrast media\n* Renal Insufficiency\n* Recent evolving, acute stroke within 21 days of study evaluation\n* Myocardial infarction within 72 hours prior to stent procedure\n* History of a prior major ipsilateral stroke with residual neurological deficits likely to confound the neurological assessments (e.g., NIHSS)\n* Neurological deficits not due to stroke likely to confound the neurological assessments (e.g., NIHSS)\n\nAngiographic Exclusion Criteria:\n\n* Isolated ipsilateral hemisphere leading to subject intolerance to reverse flow\n* Total occlusion of the ipsilateral carotid artery\n* Pre-existing stent in the ipsilateral carotid artery OR the contralateral carotid artery that extends into the aortic arch\n* Presence of a filling defect, thrombus, occlusion or "string sign" in the target vessel\n* Severe lesion calcification restricting stent deployment\n* Carotid stenosis located distal to target stenosis that is more severe than target stenosis\n* \\>50% stenosis of the CCA proximal to target vessel\n* Known mobile plaque in the aortic arch'}, 'identificationModule': {'nctId': 'NCT00766493', 'acronym': 'EMBOLDEN', 'briefTitle': 'GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'W.L.Gore & Associates'}, 'officialTitle': 'GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (GORE EMBOLDEN)', 'orgStudyIdInfo': {'id': 'GEF-06-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GORE® Embolic Filter', 'description': 'Subjects treated with the GORE® Embolic Filter and an FDA-approved carotid stent.', 'interventionNames': ['Device: GORE® Embolic Filter']}], 'interventions': [{'name': 'GORE® Embolic Filter', 'type': 'DEVICE', 'description': 'Embolic protection during carotid stenting', 'armGroupLabels': ['GORE® Embolic Filter']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'William A. Gray, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'W.L.Gore & Associates', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}