Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-28 @ 7:36 AM
Study NCT ID:
NCT01222104
Status:
COMPLETED
Last Update Posted:
2019-02-05
First Post:
2010-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Angio-Seal Interventional Radiology (IR) Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'acampbell2@sjm.com', 'phone': '651-756-5538', 'title': 'Andrew Campbell', 'organization': 'St Jude Medical'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Major and minor vascular complications were collected as Serious Adverse Event and Other Adverse Events as defined in the protocol.'}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'otherNumAtRisk': 634, 'otherNumAffected': 4, 'seriousNumAtRisk': 634, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Ipsilateral hematoma >10cm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 634, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Vascular injury requiring repair via surgery or other means', 'stats': [{'groupId': 'EG000', 'numAtRisk': 634, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New ipsilateral lower extremity ischemia requiring intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 634, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retroperitoneal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 634, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 634, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Major Vascular Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}]}, {'units': 'Procedures', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Angio -Seal', 'description': 'Angio-Seal attempted and/or deployed group'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Collect data on patients who have undergone a diagnostic and/or interventional radiology procedure in which the St. Jude Medical (SJM) Angio-Seal Evolution or V-Twist Integrated Platform (VIP) Device was deployed, to evaluate the rate of major vascular complications out to 30 days post-procedure.\n\nThe following are defined as a major vascular complication:\n\n1. Vascular injury requiring repair via surgery, angioplasty, ultrasound guided compression, thrombin injection, or other means;\n2. Permanent (unresolved at 30-day post-procedure evaluation) access site-related nerve injury or access site-related nerve injury requiring intervention;\n3. Access site related bleeding requiring transfusion;\n4. New ipsilateral lower extremity ischemia requiring surgical intervention;\n5. Retroperitoneal bleeding;\n6. Generalized infection requiring prolonged hospitalization and/or treatment with IV antibiotics;\n7. Access related complication that results in extended hospital stay;\n8. Death', 'unitOfMeasure': 'Percentage of Procedures', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures', 'populationDescription': '5 subjects underwent vascular closure with Angio-Seal on right and left sides.'}, {'type': 'SECONDARY', 'title': 'Time to Hemostasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}]}, {'units': 'Procedures', 'counts': [{'value': '529', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Angio-Seal', 'description': 'Secondary outcome reported in subjects with successful Angio-Seal deployment which achieved hemostasis by device.'}], 'classes': [{'title': 'Hemostasis less than 1 minute', 'categories': [{'measurements': [{'value': '84.9', 'groupId': 'OG000'}]}]}, {'title': 'Hemostasis between 1-5 minutes', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}]}]}, {'title': 'Hemostasis greater than 5 minutes', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Procedure', 'description': 'Time-to-hemostasis stratified into 3 categories: hemostasis in less than 1 minute alone or in combination with manual compression (standard of care), 1-5 minutes alone or in combination with manual compression (standard of care), and/or hemostasis achieved \\>5 minutes and/or with additional hemostasis methods required.', 'unitOfMeasure': '% of procedures', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures'}, {'type': 'SECONDARY', 'title': 'Rate of Minor Vascular Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}]}, {'units': 'Procedures', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'The following are defined as a minor vascular complication:\n\n1. Unanticipated access site bleeding requiring ≥ 30 minutes of manual compression to re-achieve hemostasis;\n2. Ipsilateral hematoma \\>10 cm;\n3. Ipsilateral pseudoaneurysm without intervention;\n4. Ipsilateral arteriovenous fistula;\n5. Ipsilateral deep vein thrombosis;\n6. Local access site infection without prolonged hospitalization', 'unitOfMeasure': '% of procedures with minor vasc comp.', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures'}, {'type': 'SECONDARY', 'title': 'Impact of Guided Access on Use of Closure Device.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '634', 'groupId': 'OG000'}]}, {'units': 'Procedures', 'counts': [{'value': '639', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All enrolled participants'}], 'classes': [{'title': 'Ultrasound only, n=30 procedures', 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000'}]}]}, {'title': 'Fluorscopy only, n=309 procedures', 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000'}]}]}, {'title': 'Fluoro and ultrasound, n=144 procedures', 'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000'}]}]}, {'title': 'Neither fluoro nor ultrasound, n=156 procedures', 'categories': [{'measurements': [{'value': '73.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'The influence of fluoroscopy and/or ultrasound guided access on the decision to use a closure device.', 'unitOfMeasure': '% of procedures using a closure device', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures', 'populationDescription': 'Percentage of procedures with devices deployed'}, {'type': 'SECONDARY', 'title': 'Impact of Guided Access on Achieving Target Puncture Location.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '468', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants With Deployments and Readable Angiograms'}], 'classes': [{'title': 'Ultrasound only, n=23 participants', 'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000'}]}]}, {'title': 'Fluoroscopy only, n=240 participants', 'categories': [{'measurements': [{'value': '81.7', 'groupId': 'OG000'}]}]}, {'title': 'Both Fluoro and ultrasound, n=113 participants', 'categories': [{'measurements': [{'value': '77.0', 'groupId': 'OG000'}]}]}, {'title': 'Neither fluoro nor ultrasound, n=92 participants', 'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'The influence of fluoroscopy and/or ultrasound guided access on puncture location.', 'unitOfMeasure': '% within target zone', 'reportingStatus': 'POSTED', 'populationDescription': 'Deployed subjects with readable angiograms'}, {'type': 'SECONDARY', 'title': 'Rate of Major Vascular Complications (MVCs) by Guided Access Mode.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}]}, {'units': 'Procedures', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Deployments', 'description': 'Participants with successful or attempted Angio-Seal deployments'}], 'classes': [{'title': 'Ultrasound only, n=27 procedures', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Fluoroscopy only, n=269 procedures', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Fluoro and ultrasound, n=128 procedures', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Neither fluoro nor ultrasound, n=115 procedures', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'The influence of fluoroscopy and/or ultrasound guided access on Major Vascular Complications (MVCs).', 'unitOfMeasure': '% of procedures with MVCs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures'}, {'type': 'SECONDARY', 'title': 'Rate of Minor Vascular Complications by Guided Access Mode.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}]}, {'units': 'Procedures', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Deployments', 'description': 'Participants with successful or attempted Angio-Seal deployments'}], 'classes': [{'title': 'Ultrasound only, n=27 procedures', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Fluoroscopy only, n=269 procedures', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Fluoro and ultrasound, n=128 procedures', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Neither fluoro nor ultrasound, n=115 procedures', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'The influence of fluoroscopy and/or ultrasound guided access on minor vascular complications.', 'unitOfMeasure': '% of procedures with minor vasc comp.', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures'}, {'type': 'SECONDARY', 'title': 'Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '634', 'groupId': 'OG000'}]}, {'units': 'Procedures', 'counts': [{'value': '639', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants'}], 'classes': [{'title': 'Non-PVD procedures, n=248', 'categories': [{'measurements': [{'value': '93.1', 'groupId': 'OG000'}]}]}, {'title': 'PVD procedures, n=391', 'categories': [{'measurements': [{'value': '78.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Presence of peripheral vascular disease (PVD) and its effect on the decision to use a closure device', 'unitOfMeasure': '% of procedures using closure device', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures'}, {'type': 'SECONDARY', 'title': 'Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}]}, {'units': 'Procedures', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Deployments', 'description': 'Participants with successful or attempted Angio-Seal deployments'}], 'classes': [{'title': 'Non-PVD procedures, n=232', 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000'}]}]}, {'title': 'PVD procedures, n=307', 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Presence of peripheral vascular disease (PVD) and its effect on hemostasis. Initial hemostasis by device achieved.', 'unitOfMeasure': '% of procedures achieving hemostasis', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures'}, {'type': 'SECONDARY', 'title': 'Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}]}, {'units': 'Procedures', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Deployments', 'description': 'Participants with successful or attempted Angio-Seal deployments'}], 'classes': [{'title': 'Non-PVD procedures, n=232', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'PVD procedures, n=307', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Presence of peripheral vascular disease (PVD) and its effect on Major Vascular Complications (MVC).', 'unitOfMeasure': '% of procedures with MVCs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures'}, {'type': 'SECONDARY', 'title': 'Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}]}, {'units': 'Procedures', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Deployment', 'description': 'Participants with successful or attempted Angio-Seal deployments'}], 'classes': [{'title': 'Non-PVD procedures, n=232', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'PVD procedures, n=307', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Presence of peripheral vascular disease (PVD) and its effect on minor vascular complications.', 'unitOfMeasure': '% of procedures with minor vasc comp.', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '634'}]}, {'type': 'Angio-Seal Deployment Attempted', 'achievements': [{'groupId': 'FG000', 'numSubjects': '534'}]}, {'type': 'Successful Deployment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '529'}]}, {'type': 'Successful Deployment and Hemostasis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '524'}]}, {'type': 'Completed 30-day Visit-Angio-Seal', 'achievements': [{'groupId': 'FG000', 'numSubjects': '497'}]}, {'type': 'Completed 30-day Visit-No Angio-Seal', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '587'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '634', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.6', 'spread': '14.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '328', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '306', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '634', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 634}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2010-10-05', 'resultsFirstSubmitDate': '2014-04-28', 'studyFirstSubmitQcDate': '2010-10-14', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-11-07', 'studyFirstPostDateStruct': {'date': '2010-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Major Vascular Complications', 'timeFrame': '30 days', 'description': 'Collect data on patients who have undergone a diagnostic and/or interventional radiology procedure in which the St. Jude Medical (SJM) Angio-Seal Evolution or V-Twist Integrated Platform (VIP) Device was deployed, to evaluate the rate of major vascular complications out to 30 days post-procedure.\n\nThe following are defined as a major vascular complication:\n\n1. Vascular injury requiring repair via surgery, angioplasty, ultrasound guided compression, thrombin injection, or other means;\n2. Permanent (unresolved at 30-day post-procedure evaluation) access site-related nerve injury or access site-related nerve injury requiring intervention;\n3. Access site related bleeding requiring transfusion;\n4. New ipsilateral lower extremity ischemia requiring surgical intervention;\n5. Retroperitoneal bleeding;\n6. Generalized infection requiring prolonged hospitalization and/or treatment with IV antibiotics;\n7. Access related complication that results in extended hospital stay;\n8. Death'}], 'secondaryOutcomes': [{'measure': 'Time to Hemostasis', 'timeFrame': 'Procedure', 'description': 'Time-to-hemostasis stratified into 3 categories: hemostasis in less than 1 minute alone or in combination with manual compression (standard of care), 1-5 minutes alone or in combination with manual compression (standard of care), and/or hemostasis achieved \\>5 minutes and/or with additional hemostasis methods required.'}, {'measure': 'Rate of Minor Vascular Complications', 'timeFrame': '30 days', 'description': 'The following are defined as a minor vascular complication:\n\n1. Unanticipated access site bleeding requiring ≥ 30 minutes of manual compression to re-achieve hemostasis;\n2. Ipsilateral hematoma \\>10 cm;\n3. Ipsilateral pseudoaneurysm without intervention;\n4. Ipsilateral arteriovenous fistula;\n5. Ipsilateral deep vein thrombosis;\n6. Local access site infection without prolonged hospitalization'}, {'measure': 'Impact of Guided Access on Use of Closure Device.', 'timeFrame': '30 days', 'description': 'The influence of fluoroscopy and/or ultrasound guided access on the decision to use a closure device.'}, {'measure': 'Impact of Guided Access on Achieving Target Puncture Location.', 'timeFrame': '30 days', 'description': 'The influence of fluoroscopy and/or ultrasound guided access on puncture location.'}, {'measure': 'Rate of Major Vascular Complications (MVCs) by Guided Access Mode.', 'timeFrame': '30 days', 'description': 'The influence of fluoroscopy and/or ultrasound guided access on Major Vascular Complications (MVCs).'}, {'measure': 'Rate of Minor Vascular Complications by Guided Access Mode.', 'timeFrame': '30 days', 'description': 'The influence of fluoroscopy and/or ultrasound guided access on minor vascular complications.'}, {'measure': 'Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device', 'timeFrame': '30 days', 'description': 'Presence of peripheral vascular disease (PVD) and its effect on the decision to use a closure device'}, {'measure': 'Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device', 'timeFrame': '30 days', 'description': 'Presence of peripheral vascular disease (PVD) and its effect on hemostasis. Initial hemostasis by device achieved.'}, {'measure': 'Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD)', 'timeFrame': '30 days', 'description': 'Presence of peripheral vascular disease (PVD) and its effect on Major Vascular Complications (MVC).'}, {'measure': 'Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD)', 'timeFrame': '30 days', 'description': 'Presence of peripheral vascular disease (PVD) and its effect on minor vascular complications.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vascular closure', 'Angio-Seal', 'Interventional radiology', 'femoral artery'], 'conditions': ['Diagnostic and/or Interventional Radiology Procedures']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect data on the standard of care use of the St. Jude Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in diagnostic and/or interventional radiology patient populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who undergo a diagnostic and/or interventional radiology procedure through percutaneous femoral artery access and meet the registry selection criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient is undergoing a diagnostic and/or interventional radiology procedure via femoral arterial access and the investigator performing the procedure would use Angio-Seal for closure as part of his/her routine care of the patient. Angio-Seal deployment will follow the standard of care for vascular closure device use and the Instructions for Use (IFU) for the device.\n2. Sheath angiography prior to Angio-Seal deployment reveals appropriate anatomy and puncture location for vascular closure device deployment.\n\nExclusion Criteria:\n\n1\\. Patients who are unable to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT01222104', 'briefTitle': 'Angio-Seal Interventional Radiology (IR) Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Clinical Registry of St. Jude Medical Angio-Seal™ Vascular Closure Devices Following Interventional Radiology Procedures', 'orgStudyIdInfo': {'id': '0903'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Angio-Seal', 'description': 'Angio-Seal attempted and/or deployed'}, {'label': 'Not deployed', 'description': 'Other method of closure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Cardiac and Vascular Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '14209', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Kaleida Health', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mayfield Clinic, Inc.; The University Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Riverside Methodist Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Albert Einstein Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Zoltan Turi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cooper University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}