Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT03816202
Status:
COMPLETED
Last Update Posted:
2022-01-14
First Post:
2019-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)
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': 'andrew.tummon@integralife.com', 'phone': '609-936-5490', 'title': 'Andrew Tummon, Director, Global Clinical Trials', 'organization': 'Integra LifeSciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Retrospective chart review of AEs that occurred between Surgery (Day 0) and 60 days post-operatively.', 'eventGroups': [{'id': 'EG000', 'title': 'Sundt Carotid Shunt', 'description': 'number of cases where there is evidence of injury to the artery or cerebral ischemia injury secondary to shunt placement and removal', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 3, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cerebral Ischemia Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Artery injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sundt Carotid Shunt', 'description': 'Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 60 days post-procedure', 'description': 'Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'number of cases where there is evidence of injury to the artery or cerebral ischemia injury secondary to shunt placement and removal'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sundt Carotid Shunt', 'description': 'Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sundt Carotid Shunt', 'description': 'Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '68.5', 'spread': '6.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-28', 'size': 371142, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-01T15:59', 'hasProtocol': True}, {'date': '2019-12-09', 'size': 471193, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-20T12:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-07', 'studyFirstSubmitDate': '2019-01-22', 'resultsFirstSubmitDate': '2021-06-29', 'studyFirstSubmitQcDate': '2019-01-22', 'lastUpdatePostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-07', 'studyFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal', 'timeFrame': 'up to 60 days post-procedure', 'description': 'Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Carotid Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects participating in the study have undergone a carotid endarterectomy procedure with the use of the Sundt™ carotid shunt prior to study initiation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18-80 years old\n* Have undergone carotid endarterectomy with any Integra Sundt™ carotid shunt on or before date of study initiation\n* Availability of records on post-operative imaging of the carotid artery either by carotid duplex ultrasound or angiogram\n\nExclusion Criteria:\n\n* Insertion of a carotid shunt at the site of an infection'}, 'identificationModule': {'nctId': 'NCT03816202', 'briefTitle': 'Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integra LifeSciences Corporation'}, 'officialTitle': 'Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)', 'orgStudyIdInfo': {'id': 'C-SCS-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sundt Carotid Shunt', 'description': 'Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.', 'interventionNames': ['Device: Sundt carotid shunt']}], 'interventions': [{'name': 'Sundt carotid shunt', 'type': 'DEVICE', 'description': 'The Integra Sundt™ carotid shunts are indicated for temporary carotid artery bypass during carotid endarterectomy procedures to help protect the cerebral hemispheres from ischemia during the period of carotid artery occlusion.', 'armGroupLabels': ['Sundt Carotid Shunt']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47630', 'city': 'Newburgh', 'state': 'Indiana', 'country': 'United States', 'facility': 'Research Institute of Deaconess Clinic', 'geoPoint': {'lat': 37.94449, 'lon': -87.40529}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack Meridian Health', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Andrew Tummon', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Integra LifeSciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integra LifeSciences Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}