Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 10:30 PM
Study NCT ID:
NCT00733135
Status:
COMPLETED
Last Update Posted:
2015-08-26
First Post:
2008-08-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jean.ahlstrom@covidien.com', 'phone': '763-591-3047', 'title': 'Director of Medical Communications', 'organization': 'Covidien'}, 'certainAgreement': {'otherDetails': 'PI can not make any publication concerning the study without providing the sponsor 30 days to review it and provide comments. The Sponsor may require PI to delay publication until any factual errors are corrected. If the sponsor determines the proposed publication contains confidential information, or patentable subject matter that requires protection, the sponsor may require delay of the publication less than or equal to 90 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through 30 days post-procedure', 'eventGroups': [{'id': 'EG000', 'title': 'Study Cohort', 'description': 'All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.', 'otherNumAtRisk': 133, 'otherNumAffected': 36, 'seriousNumAtRisk': 133, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Access site adverse event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dissection, grade A or B; target vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 42, 'numAffected': 24}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Access Site AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Amputation at or below metatarsal line', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AV fistula, target vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dissection, grade A or B; target vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dissection, grade D or greater; target vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Distal embolism; plaque, thrombus (blood clot) or debris distal to the filter, clinically relevant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GI bleeding due to anticoagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension or hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction, acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseudoaneurysm, non-target vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Target vessel revascularization; non-clinically driven', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis (acute and subacute); target vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel clinical perforation, target vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other, respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Successful Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}, {'units': 'lesions', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Cohort', 'description': 'All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.0', 'groupId': 'OG000', 'lowerLimit': '87.6', 'upperLimit': '95.2'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'at the end of the procedure', 'description': 'Less than or equal to 50% residual diameter stenosis following plaque excision remaining at the target lesion(s), as adjudicated by the angiographic core laboratory', 'unitOfMeasure': 'percentage of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Number of lesions assessed by the angiographic core lab'}, {'type': 'PRIMARY', 'title': 'Major Adverse Event Free Rate 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Cohort', 'description': 'All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.1', 'groupId': 'OG000', 'lowerLimit': '88.3', 'upperLimit': '96.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'MAE was defined as a serious adverse event that results in death, acute myocardial infarction, dissection (grade C or greater), clinical perforation, pseudo-aneurysm, thrombosis, distal embolism (clinically relevant), amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Technical Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Cohort', 'description': 'All participants were treated with SilverHawk/TurboHawk™ plaque excision systems with the SpiderFX™ embolic protection device placed distally.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the end of the procedure', 'description': 'Technical Procedural Success was defined as meeting all of the following requirements:\n\n* Less than or equal to 50% residual diameter stenosis at the target lesion(s), as adjudicated by the angiographic core laboratory\n* No procedure-related Major Adverse Events (MAE), as adjudicated by the Clinical Events Committee (CEC)\n* No device malfunction causing the procedure to be aborted\n* Successful delivery and placement of the SpiderFX™ embolic protection device', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total patient population minus one patient because there was no angiographic post-treatment core lab data available.'}, {'type': 'SECONDARY', 'title': 'Residual Diameter Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}, {'units': 'lesions', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Cohort', 'description': 'All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the end of the procedure', 'description': 'This endpoint was met when there was less than 30% residual diameter stenosis following treatment with SilverHawk™ /TurboHawk™ plaque excision systems and any adjunctive therapy (if required), as adjudicated by the angiographic core laboratory.', 'unitOfMeasure': 'percentage of lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': '1 lesion not included because there is no angiographic core laboratory post-treatment data available'}, {'type': 'SECONDARY', 'title': 'Presence of Debris in Deployed SpiderFx™ Embolic Protection Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}, {'units': 'deployed filters', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Cohort', 'description': 'All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the end of the procedure', 'description': 'Presence of debris in deployed SpiderFx™ embolic protection device', 'unitOfMeasure': 'percentage of deployed filters', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'deployed filters', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Preservation of Run-off Distal to the Filter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Cohort', 'description': 'All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the end of the procedure', 'description': 'Preservation of run-off distal to SpiderFX™ distal embolic protection device was determined by angiography of run-off vessels at the end of the procedure, as adjudicated by the angiographic core laboratory.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '115/133 subjects had the required angiographic images to assess this outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Cohort', 'description': 'All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '133 subjects were enrolled in this study between October 30, 2008 and October 13, 2010. The type of location included hospitals with catheterization labs and/or vascular centers.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Cohort', 'description': 'All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '95', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.7', 'spread': '9.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '95', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-14', 'studyFirstSubmitDate': '2008-08-08', 'resultsFirstSubmitDate': '2014-06-05', 'studyFirstSubmitQcDate': '2008-08-11', 'lastUpdatePostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-05', 'studyFirstPostDateStruct': {'date': '2008-08-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful Revascularization', 'timeFrame': 'at the end of the procedure', 'description': 'Less than or equal to 50% residual diameter stenosis following plaque excision remaining at the target lesion(s), as adjudicated by the angiographic core laboratory'}, {'measure': 'Major Adverse Event Free Rate 30 Days', 'timeFrame': '30 Days', 'description': 'MAE was defined as a serious adverse event that results in death, acute myocardial infarction, dissection (grade C or greater), clinical perforation, pseudo-aneurysm, thrombosis, distal embolism (clinically relevant), amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC).'}], 'secondaryOutcomes': [{'measure': 'Technical Procedural Success', 'timeFrame': 'at the end of the procedure', 'description': 'Technical Procedural Success was defined as meeting all of the following requirements:\n\n* Less than or equal to 50% residual diameter stenosis at the target lesion(s), as adjudicated by the angiographic core laboratory\n* No procedure-related Major Adverse Events (MAE), as adjudicated by the Clinical Events Committee (CEC)\n* No device malfunction causing the procedure to be aborted\n* Successful delivery and placement of the SpiderFX™ embolic protection device'}, {'measure': 'Residual Diameter Stenosis', 'timeFrame': 'at the end of the procedure', 'description': 'This endpoint was met when there was less than 30% residual diameter stenosis following treatment with SilverHawk™ /TurboHawk™ plaque excision systems and any adjunctive therapy (if required), as adjudicated by the angiographic core laboratory.'}, {'measure': 'Presence of Debris in Deployed SpiderFx™ Embolic Protection Device', 'timeFrame': 'at the end of the procedure', 'description': 'Presence of debris in deployed SpiderFx™ embolic protection device'}, {'measure': 'Preservation of Run-off Distal to the Filter', 'timeFrame': 'at the end of the procedure', 'description': 'Preservation of run-off distal to SpiderFX™ distal embolic protection device was determined by angiography of run-off vessels at the end of the procedure, as adjudicated by the angiographic core laboratory.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['peripheral vascular disease', 'atherectomy', 'atherosclerosis', 'calcified lesions'], 'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '24402764', 'type': 'RESULT', 'citation': 'Roberts D, Niazi K, Miller W, Krishnan P, Gammon R, Schreiber T, Shammas NW, Clair D; DEFINITIVE Ca(+)(+) Investigators. Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: final results of the DEFINITIVE Ca(+)(+) trial. Catheter Cardiovasc Interv. 2014 Aug 1;84(2):236-44. doi: 10.1002/ccd.25384. Epub 2014 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, non-randomized, single arm study of the SilverHawk™ /TurboHawk™ plaque excision systems when used in conjunction with SpiderFX™ embolic protection device in treatment of moderate to severely calcified peripheral arterial disease in the superficial femoral and/or popliteal arteries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provides written informed consent\n* Willing to comply with follow-up evaluations at specified times\n* Has leg pain due to peripheral arterial disease\n* Disease located within the femoropopliteal artery\n* Moderate to severe calcification\n\nExclusion Criteria:\n\n* Previously implanted stent(s) or stent graft(s) in target leg\n* Life expectancy less than 12 months\n* Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure'}, 'identificationModule': {'nctId': 'NCT00733135', 'briefTitle': 'Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Endovascular'}, 'officialTitle': 'Determination of Safety and Effectiveness of the SilverHawk™ Peripheral Plaque Excision System for Calcium (SilverHawk LS-C) and the SpiderFX™ Embolic Protection Device for the Treatment of Calcified Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries (DEFINITIVE Ca++)', 'orgStudyIdInfo': {'id': 'FHT-P-07-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Atherectomy with embolic protection', 'description': 'All subjects were treated with atherectomy (with SilverHawk or TurboHawk device) in conjunction with embolic protection (SpiderFX device).', 'interventionNames': ['Device: SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device']}], 'interventions': [{'name': 'SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device', 'type': 'DEVICE', 'description': 'Catheter-based excision of moderate to severely calcified plaque located in the SFA and/or popliteal artery.', 'armGroupLabels': ['Atherectomy with embolic protection']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Daniel Clair, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'David Roberts, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sutter Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Endovascular', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}