Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-02-01 @ 1:09 AM
Study NCT ID:
NCT02639494
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2015-12-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Self-Centering Guide Catheter Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Gulati.Rajiv@mayo.edu', 'phone': '507-538-6325', 'title': 'Dr. Rajiv Gulati', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected through 72 hours or discharge, whichever came first. There were no Adverse Events, Serious Adverse Events or Unanticipated Adverse Device Events, reported during the study period.', 'eventGroups': [{'id': 'EG000', 'title': 'Self-Centering Guide Catheter', 'description': "Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery.", 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Self-Centering Guide Catheters Successfully Used to Deliver a Guide Wire Through the Self-Centering Guide Catheter Across the Stenotic Native Aortic Valve Into the Left Ventricle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Device', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Centering Guide Catheter', 'description': "Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery."}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Through study completion, up to 72 hours post-procedure', 'description': 'This outcome will be assessed via physician determination and will be recorded in the case report form.', 'unitOfMeasure': 'Device', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Device', 'denomUnitsSelected': 'Device', 'populationDescription': '20 patients were treated with 23 devies'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time From Insertion of the Self-Centering Guide Catheter Into the Body to Successful Placement of a PTFE-coated Guidewire Across the Stenotic Native Aortic Valve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Centering Guide Catheter', 'description': "Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery."}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '4.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, up to 72 hours post-procedure', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A guide wire was delivered through the self-centering guide catheter in 18/20 patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time From Insertion of the Self-Centering Guide Catheter Into the Body to Removal of the Self-Centering Guide Catheter From the Body', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'Devices', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Centering Guide Catheter', 'description': "Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery."}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '8.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, up to 72 hours post-procedure', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Devices', 'denomUnitsSelected': 'Devices', 'populationDescription': 'A guide wire was delivered through the self-centering guide catheter in 18/20 patients. In total 23 devices were used.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Attempts Made to Cross the Stenotic Native Aortic Valve With a PTFE-coated Guidewire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Device', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Centering Guide Catheter', 'description': "Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery."}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '7.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, up to 72 hours post-procedure', 'unitOfMeasure': 'Attempts', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Device', 'denomUnitsSelected': 'Device'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Successful Recapture of the Distal Self-centering Basket of the Device Into the Guide and Withdrawal of the Self-Centering Guide Catheter Through the Guide System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Device', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Centering Guide Catheter', 'description': "Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery."}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Through study completion, up to 72 hours post-procedure', 'description': 'The outcome measure of successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system will be assessed via physician assessment of the self-centering basket recapture and will be recorded in the case report form.', 'unitOfMeasure': 'Device', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Device', 'denomUnitsSelected': 'Device'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Self-Centering Guide Catheters With Device Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Device', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Centering Guide Catheter', 'description': "Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery."}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Through study completion, up to 72 hours post-procedure', 'description': 'Device success is defined as successful delivery of a guide wire through the Self-Centering Guide Catheter across the stenotic native aortic valve into the left ventricle and successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system. This outcome will be assessed via physician determination and will be recorded in the case report form.', 'unitOfMeasure': 'Device', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Device', 'denomUnitsSelected': 'Device'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Centering Guide Catheter', 'description': "Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours post-procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Cardiac Tamponade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Centering Guide Catheter', 'description': "Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours post-procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Death, All-cause, Cardiovascular, and Non-cardiovascular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Centering Guide Catheter', 'description': "Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours post-procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Any Device-related Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Centering Guide Catheter', 'description': "Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours post-procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Any Adverse Event Occurring While the Self-Centering Guide Catheter is in the Subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Centering Guide Catheter', 'description': "Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours post-procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Device Deficiencies Including But Not Limited to Failures, Malfunctions, Use Errors, Product Nonconformities, and Labeling Errors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Device', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Centering Guide Catheter', 'description': "Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery."}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '72 hours post-procedure', 'description': 'All device deficiencies including but not limited to failures, malfunctions, use errors, product nonconformities, and labeling errors will be recorded in the case report form', 'unitOfMeasure': 'Device', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Device', 'denomUnitsSelected': 'Device'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Self-Centering Guide Catheter', 'description': "Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Self-Centering Guide Catheter', 'description': "Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '78.0', 'spread': '9.04', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', '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': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '20', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-27', 'studyFirstSubmitDate': '2015-12-17', 'resultsFirstSubmitDate': '2017-05-31', 'studyFirstSubmitQcDate': '2015-12-21', 'lastUpdatePostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-27', 'studyFirstPostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time From Insertion of the Self-Centering Guide Catheter Into the Body to Successful Placement of a PTFE-coated Guidewire Across the Stenotic Native Aortic Valve', 'timeFrame': 'Through study completion, up to 72 hours post-procedure'}, {'measure': 'Time From Insertion of the Self-Centering Guide Catheter Into the Body to Removal of the Self-Centering Guide Catheter From the Body', 'timeFrame': 'Through study completion, up to 72 hours post-procedure'}, {'measure': 'Number of Attempts Made to Cross the Stenotic Native Aortic Valve With a PTFE-coated Guidewire', 'timeFrame': 'Through study completion, up to 72 hours post-procedure'}, {'measure': 'Successful Recapture of the Distal Self-centering Basket of the Device Into the Guide and Withdrawal of the Self-Centering Guide Catheter Through the Guide System', 'timeFrame': 'Through study completion, up to 72 hours post-procedure', 'description': 'The outcome measure of successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system will be assessed via physician assessment of the self-centering basket recapture and will be recorded in the case report form.'}, {'measure': 'Number of Self-Centering Guide Catheters With Device Success', 'timeFrame': 'Through study completion, up to 72 hours post-procedure', 'description': 'Device success is defined as successful delivery of a guide wire through the Self-Centering Guide Catheter across the stenotic native aortic valve into the left ventricle and successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system. This outcome will be assessed via physician determination and will be recorded in the case report form.'}, {'measure': 'Number of Participants With Stroke', 'timeFrame': '72 hours post-procedure'}, {'measure': 'Number of Participants With Cardiac Tamponade', 'timeFrame': '72 hours post-procedure'}, {'measure': 'Death, All-cause, Cardiovascular, and Non-cardiovascular', 'timeFrame': '72 hours post-procedure'}, {'measure': 'Any Device-related Adverse Event', 'timeFrame': '72 hours post-procedure'}, {'measure': 'Any Adverse Event Occurring While the Self-Centering Guide Catheter is in the Subject', 'timeFrame': '72 hours post-procedure'}, {'measure': 'Number of Device Deficiencies Including But Not Limited to Failures, Malfunctions, Use Errors, Product Nonconformities, and Labeling Errors', 'timeFrame': '72 hours post-procedure', 'description': 'All device deficiencies including but not limited to failures, malfunctions, use errors, product nonconformities, and labeling errors will be recorded in the case report form'}], 'primaryOutcomes': [{'measure': 'Number of Self-Centering Guide Catheters Successfully Used to Deliver a Guide Wire Through the Self-Centering Guide Catheter Across the Stenotic Native Aortic Valve Into the Left Ventricle', 'timeFrame': 'Through study completion, up to 72 hours post-procedure', 'description': 'This outcome will be assessed via physician determination and will be recorded in the case report form.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Aortic Stenosis']}, 'descriptionModule': {'briefSummary': 'An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.', 'detailedDescription': 'A prospective, open-label, single-arm feasibility study evaluating the Self-Centering Guide Catheter. All subjects who are candidates for transcatheter aortic valve replacement (TAVR) of a native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques will be evaluated for enrollment in this study. The Self-Centering Guide Catheter is intended to facilitate delivery of a guidewire across a stenotic native aortic valve and into the left ventricle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be at least 18 years of age.\n* Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.\n* Subject is eligible for and is an acceptable candidate for transcatheter aortic valve replacement of a stenotic (aortic valve area ≤1 cm2, aortic jet velocity ≥4.0 m/s, or mean gradient ≥40 mmHg) native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques.\n\nExclusion Criteria:\n\n* Subject has known hypersensitivity to the components of the device (e.g., polyether block amide, fluoropolymers, nickel, platinum, tantalum, titanium).\n* Subject has a pre-existing prosthetic aortic valve.'}, 'identificationModule': {'nctId': 'NCT02639494', 'briefTitle': 'Self-Centering Guide Catheter Feasibility Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Self-Centering Guide Catheter Feasibility Study', 'orgStudyIdInfo': {'id': 'S2360'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-Centering Guide Catheter', 'description': "Subjects who provided written informed consent and an attempt is made to insert the Self-Centering Guide Catheter into the subject's femoral artery.", 'interventionNames': ['Device: Self-Centering Guide Catheter']}], 'interventions': [{'name': 'Self-Centering Guide Catheter', 'type': 'DEVICE', 'armGroupLabels': ['Self-Centering Guide Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Rajiv Gulati, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}