Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-01-01 @ 3:29 AM
Study NCT ID:
NCT01406795
Status:
TERMINATED
Last Update Posted:
2017-02-27
First Post:
2011-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D054070', 'term': 'Postthrombotic Syndrome'}, {'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014689', 'term': 'Venous Insufficiency'}, {'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lhofmann@stanfordhealthcare.org', 'phone': '6507366096', 'title': 'Rusty Hofmann', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was underpowered, enrolling only a single patient (goal enrollment was 15 patients).'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Venous Stent Arm', 'description': 'The study is a single treatment arm study and the venous stent will be placed in all eligible participants.\n\nGore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stent Migration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venous Stent Arm', 'description': 'The study is a single treatment arm study and the venous stent will be placed in all eligible participants.\n\nGore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 month following the procedure', 'description': 'Stent migration is reported as the count of participants with stent migration within 1 month following stent placement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Stent Migration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venous Stent Arm', 'description': 'The study is a single treatment arm study and the venous stent will be placed in all eligible participants.\n\nGore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to one year following the procedure 1 year', 'description': 'Stent migration is reported as the count of participants with stent migration within 1 year following stent placement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Primary Patency Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venous Stent Arm', 'description': 'The study is a single treatment arm study and the venous stent will be placed in all eligible participants.\n\nGore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 year following the procedure', 'description': 'Patency refers to whether the stent is unoccluded (open). Primary patency rate was defined as the count of participants with \\>= 50% patency following initial stent placement, and is reported as the count of participants meeting this criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Freedom From Device-related Amputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venous Stent Arm', 'description': 'The study is a single treatment arm study and the venous stent will be placed in all eligible participants.\n\nGore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 year following the procedure', 'description': 'Freedom from device-related amputation (amputation of infected limb) is reported as the count of participants with no device-related amputation within 1 year following stent placement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assisted-primary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venous Stent Arm', 'description': 'The study is a single treatment arm study and the venous stent will be placed in all eligible participants.\n\nGore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 year', 'description': 'Patency refers to whether the stent is unoccluded (open). Primary refers to the first time a stent was placed (or the first time patency needed to be established). Assisted refers to the fact that a device (like a balloon) was used to open the stent. Assisted-primary patency is defined as the count of participants that demonstrated the need for an intervention to establish patency.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Secondary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venous Stent Arm', 'description': 'The study is a single treatment arm study and the venous stent will be placed in all eligible participants.\n\nGore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 year', 'description': 'Secondary patency means that the initial intervention failed and a second intervention was performed to establish or maintain patency. Secondary patency is defined as the count of participants that required a second intervention to establish patency.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venous Stent Arm', 'description': 'The study is a single treatment arm study and the venous stent will be placed in all eligible participants.\n\nGore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to two years 2 years', 'description': 'Adverse events were reported as the count of participants that experienced an adverse event within two years of their procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Decrease in Swelling of Affected Extremity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venous Stent Arm', 'description': 'The study is a single treatment arm study and the venous stent will be placed in all eligible participants.\n\nGore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 2 years', 'description': 'The count of participants that experienced a decrease in swelling after the stent was placed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Venous Clinical Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venous Stent Arm', 'description': 'The study is a single treatment arm study and the venous stent will be placed in all eligible participants.\n\nGore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.'}], 'timeFrame': 'up to 2 years', 'description': 'Venous Clinical Severity represents the severity of the venous pathology, which includes measures like pain, inflammation, and number of ulcers. It is scored on a scale of 0-3 with the upper end representing very severe outcomes for the patient.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome'}, {'type': 'SECONDARY', 'title': 'VEINS-QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venous Stent Arm', 'description': 'The study is a single treatment arm study and the venous stent will be placed in all eligible participants.\n\nGore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 years', 'description': "The VEINS-QOL is a questionnaire that represents a patient's quality of life, using measures like how well the patient can walk, sleep, and enjoy life. Responses are graded on a scale of 1-5, with 1 being very good, and 5 being very poor. The VEINS-QOL measure is defined by the count of participants that showed a decreased overall score following their procedure.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Villalta PTS Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venous Stent Arm', 'description': 'The study is a single treatment arm study and the venous stent will be placed in all eligible participants.\n\nGore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.'}], 'timeFrame': 'up to 2 years', 'description': "The Villalta PTS Scale is a score based on the patient's symptoms, includes cramps, pain, and redness. It is scaled from 0 to 48, with a higher score representing more severe disease.", 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Venous Stent Arm', 'description': 'The study is a single treatment arm study and the venous stent will be placed in all eligible participants.\n\nGore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study recruited a single patient in 2012 at the Stanford Medical Center. The study ended in 2013.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Venous Stent Arm', 'description': 'The study is a single treatment arm study and the venous stent will be placed in all eligible participants.\n\nGore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Poor enrollment and advances in venoplasty only techniques of the femoral vein', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-06', 'studyFirstSubmitDate': '2011-07-22', 'resultsFirstSubmitDate': '2016-11-24', 'studyFirstSubmitQcDate': '2011-07-28', 'lastUpdatePostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-06', 'studyFirstPostDateStruct': {'date': '2011-08-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stent Migration', 'timeFrame': 'up to 1 month following the procedure', 'description': 'Stent migration is reported as the count of participants with stent migration within 1 month following stent placement.'}, {'measure': 'Stent Migration', 'timeFrame': 'up to one year following the procedure 1 year', 'description': 'Stent migration is reported as the count of participants with stent migration within 1 year following stent placement.'}, {'measure': 'Primary Patency Rate', 'timeFrame': 'up to 1 year following the procedure', 'description': 'Patency refers to whether the stent is unoccluded (open). Primary patency rate was defined as the count of participants with \\>= 50% patency following initial stent placement, and is reported as the count of participants meeting this criteria.'}], 'secondaryOutcomes': [{'measure': 'Freedom From Device-related Amputation', 'timeFrame': 'up to 1 year following the procedure', 'description': 'Freedom from device-related amputation (amputation of infected limb) is reported as the count of participants with no device-related amputation within 1 year following stent placement.'}, {'measure': 'Assisted-primary Patency', 'timeFrame': 'up to 1 year', 'description': 'Patency refers to whether the stent is unoccluded (open). Primary refers to the first time a stent was placed (or the first time patency needed to be established). Assisted refers to the fact that a device (like a balloon) was used to open the stent. Assisted-primary patency is defined as the count of participants that demonstrated the need for an intervention to establish patency.'}, {'measure': 'Secondary Patency', 'timeFrame': 'up to 1 year', 'description': 'Secondary patency means that the initial intervention failed and a second intervention was performed to establish or maintain patency. Secondary patency is defined as the count of participants that required a second intervention to establish patency.'}, {'measure': 'Adverse Events', 'timeFrame': 'up to two years 2 years', 'description': 'Adverse events were reported as the count of participants that experienced an adverse event within two years of their procedure.'}, {'measure': 'Decrease in Swelling of Affected Extremity', 'timeFrame': 'up to 2 years', 'description': 'The count of participants that experienced a decrease in swelling after the stent was placed.'}, {'measure': 'Venous Clinical Severity Score', 'timeFrame': 'up to 2 years', 'description': 'Venous Clinical Severity represents the severity of the venous pathology, which includes measures like pain, inflammation, and number of ulcers. It is scored on a scale of 0-3 with the upper end representing very severe outcomes for the patient.'}, {'measure': 'VEINS-QOL', 'timeFrame': 'Up to 2 years', 'description': "The VEINS-QOL is a questionnaire that represents a patient's quality of life, using measures like how well the patient can walk, sleep, and enjoy life. Responses are graded on a scale of 1-5, with 1 being very good, and 5 being very poor. The VEINS-QOL measure is defined by the count of participants that showed a decreased overall score following their procedure."}, {'measure': 'Villalta PTS Scale', 'timeFrame': 'up to 2 years', 'description': "The Villalta PTS Scale is a score based on the patient's symptoms, includes cramps, pain, and redness. It is scaled from 0 to 48, with a higher score representing more severe disease."}]}, 'conditionsModule': {'keywords': ['Post Thrombotic Syndrome', 'Venous Stasis', 'Venous Occlusions', 'Venous Stenosis'], 'conditions': ['Venous Thrombosis']}, 'descriptionModule': {'briefSummary': 'To study the safety and efficacy of drug coated stents for the treatment of venous occlusions and stenoses in the lower extremity. The use of the device for the treatment of peripheral arterial disease is approved by the FDA, however, the use of the device in venous occlusions and stenoses, although performed by some practitioners, has not yet been studied in detail.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is at least 18 years old\n* Patient has clinical manifestations (i.e. symptoms and/or signs) of chronic DVT of an extremity. The Venous Clinical Severity Score (VCSS) will be used to determine if the patient is currently suffering from chronic DVT, with a VCSS score of 4 or greater necessary for inclusion.\n* Imaging confirmation of venous occlusion or stenosis (\\>50%) involving the femoral, and/or popliteal veins\n* Obstructed vessel caliber can accommodate a 7FR System, from insertion site to target segment\n* Patient is able to read and answer a questionnaire in English\n\nExclusion Criteria:\n\n* History of life-threatening reaction to contrast material\n* Unwilling or unable to provide informed consent, or return for required follow-up evaluations\n* Participating in another investigational study that has not completed follow-up testing\n* Cannot receive outpatient anticoagulation such as LMWH and/or vitamin K antagonists (VKAs)\n* Absolute contraindication to contrast media or renal insufficiency (baseline creatinine \\>2.0 mg/dL).\n* Either a history or presence of heparin-induced thrombocytopenia antibodies'}, 'identificationModule': {'nctId': 'NCT01406795', 'briefTitle': 'The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Evaluation of GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface for the Treatment of Venous Occlusions and Stenoses', 'orgStudyIdInfo': {'id': 'SU-01312011-7377'}, 'secondaryIdInfos': [{'id': 'FDA IDE - G090054'}, {'id': 'IRB eProtocol - 14781'}, {'id': 'SPO # 49275'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Venous Stent Arm', 'description': 'The study is a single treatment arm study and the venous stent will be placed in all eligible participants.', 'interventionNames': ['Device: Gore Viabahn Heparin Coated Stent']}], 'interventions': [{'name': 'Gore Viabahn Heparin Coated Stent', 'type': 'DEVICE', 'description': 'For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.', 'armGroupLabels': ['Venous Stent Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Dr. Lawrence (Rusty) Hofmann MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Interventional Radiology', 'investigatorFullName': 'Lawrence (Rusty) Hofmann', 'investigatorAffiliation': 'Stanford University'}}}}