Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2026-01-01 @ 9:25 AM
Study NCT ID:
NCT02948257
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2016-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
VASCADE ANTEGRADE-PVD Post-Market Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Terry_Alverson@cardivamedical.com', 'phone': '408-470-7119', 'title': 'Terry Alverson, Director of Regulatory and Clinical', 'organization': 'Cardiva Medical'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'VASCADE VCS', 'description': 'The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 11, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Access site arterial re-bleeding after initial hemostasis', 'notes': 'Access site arterial re-bleeding after initial hemostasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Residual hematoma < 6 cm', 'notes': 'Residual hematoma \\< 6 cm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tissue tract oozing - prolonged', 'notes': 'Tissue tract oozing - prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseudoaneurysm not requiring repair', 'notes': 'Pseudoaneurysm not requiring repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising', 'notes': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Groin pain', 'notes': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina', 'notes': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening PVD', 'notes': 'Worsening PVD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'notes': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mechanical Fall', 'notes': 'Mechanicall Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Chronic osteomyelitis of ankle/foot', 'notes': 'Chronic osteomyelitis of ankle/foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'notes': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'notes': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Kidney Injury', 'notes': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Hemostasis (TTH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VASCADE VCS', 'description': 'The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.87', 'spread': '2.44', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Procedural, usually within 15 minutes of enrollment', 'description': 'Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Major Access Site Closure-related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VASCADE VCS', 'description': 'The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 30 days +/- 7 days', 'description': 'Patient incident rate of combined major access site closure-related complications through 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Ambulation (TTA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VASCADE VCS', 'description': 'The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.48', 'spread': '3.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to discharge, usually within 24 hours', 'description': 'Time to Ambulation (TTA) is defined as elapsed time between VASCADE device removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Discharge (TTD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VASCADE VCS', 'description': 'The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.97', 'spread': '5.85', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through hospital discharge, usually within 24 hours', 'description': 'Time to Discharge (TTD) is defined as elapsed time between VASCADE device removal and discharge from the facility.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Device Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VASCADE VCS', 'description': 'The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Procedural, usually within 15 minutes of enrollment', 'description': 'Device Success is defined as the ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Cardiva VASCADE VCS alone or with adjunctive compression.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Procedure Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VASCADE VCS', 'description': 'The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 30 +/- 7 days', 'description': 'Procedure Success is defined as attainment of Device Success and freedom from major access site closure-related complications through 30 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Minor Access Site Closure-related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VASCADE VCS', 'description': 'The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 30 +/- 7 days', 'description': 'Patient incident rate of combined minor access site closure-related complications through 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VASCADE VCS', 'description': 'The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'VASCADE VCS', 'description': 'The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'spread': '9.86', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI (Body Mass Index)', 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'spread': '4.46', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-07', 'size': 1948517, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2020-01-03T14:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-06', 'studyFirstSubmitDate': '2016-10-26', 'resultsFirstSubmitDate': '2020-01-06', 'studyFirstSubmitQcDate': '2016-10-26', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-06', 'studyFirstPostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Hemostasis (TTH)', 'timeFrame': 'Procedural, usually within 15 minutes of enrollment', 'description': 'Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis.'}, {'measure': 'Major Access Site Closure-related Complications', 'timeFrame': 'Through 30 days +/- 7 days', 'description': 'Patient incident rate of combined major access site closure-related complications through 30 days'}], 'secondaryOutcomes': [{'measure': 'Time to Ambulation (TTA)', 'timeFrame': 'Prior to discharge, usually within 24 hours', 'description': 'Time to Ambulation (TTA) is defined as elapsed time between VASCADE device removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site.'}, {'measure': 'Time to Discharge (TTD)', 'timeFrame': 'Through hospital discharge, usually within 24 hours', 'description': 'Time to Discharge (TTD) is defined as elapsed time between VASCADE device removal and discharge from the facility.'}, {'measure': 'Device Success', 'timeFrame': 'Procedural, usually within 15 minutes of enrollment', 'description': 'Device Success is defined as the ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Cardiva VASCADE VCS alone or with adjunctive compression.'}, {'measure': 'Procedure Success', 'timeFrame': 'Through 30 +/- 7 days', 'description': 'Procedure Success is defined as attainment of Device Success and freedom from major access site closure-related complications through 30 days.'}, {'measure': 'Minor Access Site Closure-related Complications', 'timeFrame': 'Through 30 +/- 7 days', 'description': 'Patient incident rate of combined minor access site closure-related complications through 30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vessel closure', 'Antegrade access', 'Femoral arteriotomy', 'Peripheral endovascular interventions'], 'conditions': ['Surgical Wound']}, 'referencesModule': {'references': [{'pmid': '25740963', 'type': 'BACKGROUND', 'citation': 'Hermiller JB, Leimbach W, Gammon R, Karas SP, Whitbourn RJ, Wong SC, Goswami N, McCabe J, Cavros NG, Paulus R, Naidu SS, Turi ZG. A prospective, randomized, pivotal trial of a novel extravascular collagen-based closure device compared to manual compression in diagnostic and interventional patients. J Invasive Cardiol. 2015 Mar;27(3):129-36.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7F introducer sheaths via an antegrade approach.', 'detailedDescription': 'Due to the growing adoption of antegrade femoral access and the use of VCDs to close these arteriotomies, it is important to collect performance and complication outcomes data related to this procedural variable. The aim of this registry is to consistently collect prospective data on procedural outcomes on antegrade access cases closed with the VASCADE VCS in a way that is consistent with the RESPECT Study design and the FDA-approved Instructions for Use (IFU).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acceptable candidate for an elective, non-emergent ipsilateral peripheral interventional endovascular procedure via antegrade access of the femoral artery using a 5, 6 or 7 Fr introducer sheath', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acceptable candidate for post-procedural manual compression\n* Able to ambulate at least 20 feet, with or without assistance\n\nExclusion Criteria:\n\n* Active systemic or cutaneous infection or inflammation\n* Ipsilateral femoral arteriotomy with any of the following conditions: a) access within \\< or = 10 days; b) any residual hematoma, significant bruising, or known associated vascular complications; or c) within \\< or = 90 days, use of an intra-vascular closure device (i.e., Angioseal)\n* Previous vascular grafts or surgery at the target vessel access site\n* Major amputation of ipsilateral lower extremity - previous history of, or planned within next 30 days prior to study exit\n* Extreme morbid obesity (BMI greater than 4 kg/m2) or underweight (BMI less than 20 kg/m2)\n* Femoral arterial diameter \\< 6 mm at access site\n* Antegrade arterial access site is a side stick and/or is not a single anterior wall femoral puncture\n* Length of tissue tract, the distance between the anterior arterial wall and skin, is \\< 2.5 cm.'}, 'identificationModule': {'nctId': 'NCT02948257', 'briefTitle': 'VASCADE ANTEGRADE-PVD Post-Market Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardiva Medical, Inc.'}, 'officialTitle': 'Multi-center, Prospective, PM Registry for Procedural Outcomes Using the Cardiva VASCADE VCS for Closing the Femoral Arteriotomy After Percutaneous Endovascular Procedures Via Antegrade Access.', 'orgStudyIdInfo': {'id': 'PTL 0502-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cardiva Medical VASCADE VCS', 'type': 'DEVICE', 'description': 'At the end of peripheral endovascular interventional procedures performed via an antegrade femoral arterial approach, the femoral arterial access site is closed with the VASCADE VCS to achieve arterial hemostasis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70360', 'city': 'Houma', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Cardiovascular Institute of the South', 'geoPoint': {'lat': 29.59577, 'lon': -90.71953}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'North MS Medical Center', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Coastal Surgery Specialists', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio Endovascular and Heart Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Mehdi Shishehbor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiva Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}