Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-01-02 @ 8:19 AM
Study NCT ID:
NCT03362957
Status:
COMPLETED
Last Update Posted:
2021-03-22
First Post:
2017-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Geniculate Artery Embolization for Knee Pain Secondary to Osteoarthritis (OA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rad_research@med.unc.edu', 'phone': '919-966-4997', 'title': 'Associate Director of Clinical Research Operations, Department of Radiology', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse events were captured following the Sham procedure for 1 month and for the GAE procedure for the duration of the study, approximately 12 months', 'eventGroups': [{'id': 'EG000', 'title': 'GAE Procedure', 'description': 'Patients will be randomized to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 8, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Procedure', 'description': 'Patients will be randomized to a sham procedure.\n\nSham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 2, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Crossover Arm', 'description': 'If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Knee pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'bleeding at access site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean WOMAC Scores at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GAE Procedure', 'description': 'Patients will be randomized to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}, {'id': 'OG001', 'title': 'Sham Procedure', 'description': 'Patients will be randomized to a sham procedure.\n\nSham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram'}, {'id': 'OG002', 'title': 'Crossover Arm', 'description': 'If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'spread': '25', 'groupId': 'OG000'}, {'value': '26', 'spread': '31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months following procedure', 'description': 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC) will be used to measure function. This is a score derived from a questionnaire in which the patient answers questions regarding rheumatic symptoms in the subcategories of pain (5 items), stiffness (2 items), and physical function (17 items). Individuals select the level of difficulty they have performing various tasks using a 5 point Likert scale (0=None, 1=Slightly, 3=Very, 4=Extremely). Then, results are scored with a total score (minimum 0; maximum 96). A higher score indicates more difficulty in each of the categories.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was excluded from the GAE arm due to increased pain that resulted in additional medication and was excluded from the analysis. All sham participants crossed over to receive treatment after 1 month, thus no 6-month data available for this group. One crossover participant did not have WOMAC data available for the 6 month visit.'}, {'type': 'PRIMARY', 'title': 'Mean Patient Pain as Measured by VAS at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GAE Procedure', 'description': 'Patients will be randomized to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}, {'id': 'OG001', 'title': 'Sham Procedure', 'description': 'Patients will be randomized to a sham procedure.\n\nSham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram'}, {'id': 'OG002', 'title': 'Crossover Arm', 'description': 'If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.3', 'spread': '25.6', 'groupId': 'OG000'}, {'value': '19.2', 'spread': '35.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months following procedure', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain will be assessed at each of the patient\'s follow-up visits and used to measure the change from baseline (prior to the GAE procedure). The investigators will use this to measure if the patient\'s pain level decreases.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was excluded from the GAE arm due to increased pain that resulted in additional medication and was excluded from the analysis. All sham participants crossed over to receive treatment after 1 month, thus no 6-month data available for this group. One patient in the crossover arm did not have VAS data available for the 6 month visit.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reduction in Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GAE Procedure', 'description': 'Patients will be randomized to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}, {'id': 'OG001', 'title': 'Sham Procedure', 'description': 'Patients will be randomized to a sham procedure.\n\nSham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram'}, {'id': 'OG002', 'title': 'Crossover Arm', 'description': 'If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months following procedure', 'description': 'Reduction in the number or strength of previously initiated OA medical therapy (e.g. NSAIDs) at 6 months follow-up, which will be summarized using counts.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the sham arm crossed over 1 month after the sham procedure, thus no 6-month data available for this group.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patient With Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GAE Procedure', 'description': 'Patients will be randomized to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}, {'id': 'OG001', 'title': 'Sham Procedure', 'description': 'Patients will be randomized to a sham procedure.\n\nSham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram'}, {'id': 'OG002', 'title': 'Crossover Arm', 'description': 'If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months following procedure for the "GAE Procedure" and "Crossover Arm" Arms/Groups and 1 month following procedure for the "Sham Procedure" Arm/Group', 'description': 'The number and description of complications, adverse events, or poor outcomes (such as no improvement in pain) that are secondary to the GAE procedure, which will be summarized using counts.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean WOMAC Scores at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GAE Procedure', 'description': 'Patients will be randomized to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}, {'id': 'OG001', 'title': 'Sham Procedure', 'description': 'Patients will be randomized to a sham procedure.\n\nSham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram'}, {'id': 'OG002', 'title': 'Crossover Arm', 'description': 'If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.7', 'spread': '24', 'groupId': 'OG000'}, {'value': '65.9', 'spread': '11.3', 'groupId': 'OG001'}, {'value': '46.3', 'spread': '29.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month following procedure', 'description': 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC) will be used to measure function. This is a score derived from a questionnaire in which the patient answers questions regarding rheumatic symptoms in the subcategories of pain (5 items), stiffness (2 items), and physical function (17 items). Individuals select the level of difficulty they have performing various tasks using a 5 point Likert scale (0=None, 1=Slightly, 3=Very, 4=Extremely). Then, results are scored with a total score (minimum 0; maximum 96). A higher score indicates more difficulty in each of the categories.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was excluded from the GAE arm due to increased pain that resulted in additional medication and was excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Mean Patient Pain as Measured by VAS at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GAE Procedure', 'description': 'Patients will be randomized to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}, {'id': 'OG001', 'title': 'Sham Procedure', 'description': 'Patients will be randomized to a sham procedure.\n\nSham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram'}, {'id': 'OG002', 'title': 'Crossover Arm', 'description': 'If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'spread': '27.9', 'groupId': 'OG000'}, {'value': '78.4', 'spread': '10.2', 'groupId': 'OG001'}, {'value': '39.8', 'spread': '31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month following procedure', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain will be assessed at each of the patient\'s follow-up visits and used to measure the change from baseline (prior to the GAE procedure). The investigators will use this to measure if the patient\'s pain level decreases.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was excluded from the GAE arm due to increased pain that resulted in additional medication and was excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Mean WOMAC Scores at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GAE Procedure', 'description': 'Patients will be randomized to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}, {'id': 'OG001', 'title': 'Sham Procedure', 'description': 'Patients will be randomized to a sham procedure.\n\nSham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram'}, {'id': 'OG002', 'title': 'Crossover Arm', 'description': 'If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.7', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '39.5', 'spread': '27.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months following procedure', 'description': 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC) will be used to measure function. This is a score derived from a questionnaire in which the patient answers questions regarding rheumatic symptoms in the subcategories of pain (5 items), stiffness (2 items), and physical function (17 items). Individuals select the level of difficulty they have performing various tasks using a 5 point Likert scale (0=None, 1=Slightly, 3=Very, 4=Extremely). Then, results are scored with a total score (minimum 0; maximum 96). A higher score indicates more difficulty in each of the categories.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was excluded from the GAE arm due to increased pain that resulted in additional medication and was excluded from the analysis. One additional participant in this arm did not have data available at the 3 month visit. All sham participants crossed over to receive treatment after 1 month, thus no 3-month data available for this group. One patient in the crossover arm did not have WOMAC data available for the 3 month visit.'}, {'type': 'PRIMARY', 'title': 'Mean Patient Pain as Measured by VAS at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GAE Procedure', 'description': 'Patients will be randomized to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}, {'id': 'OG001', 'title': 'Sham Procedure', 'description': 'Patients will be randomized to a sham procedure.\n\nSham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram'}, {'id': 'OG002', 'title': 'Crossover Arm', 'description': 'If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.3', 'spread': '27.9', 'groupId': 'OG000'}, {'value': '41.2', 'spread': '31.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months following procedure', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain will be assessed at each of the patient\'s follow-up visits and used to measure the change from baseline (prior to the GAE procedure). The investigators will use this to measure if the patient\'s pain level decreases.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was excluded from the GAE arm due to increased pain that resulted in additional medication and was excluded from the analysis. One additional participant in this arm did not have data available at the 3 month visit. All sham participants crossed over to receive treatment after 1 month, thus no 3-month data available for this group. One patient in the crossover arm did not have VAS data available for the 3 month visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GAE Procedure', 'description': 'Patients will be randomized to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}, {'id': 'FG001', 'title': 'Sham Procedure First, Then GAE Procedure', 'description': 'Patients will be randomized to a sham procedure.\n\nSham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram\n\nIf after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Crossover to Receive GAE Procedure', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'All patients that received the sham procedure crossed over into the crossover arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GAE Procedure', 'description': 'Patients will be randomized to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}, {'id': 'BG001', 'title': 'Sham Procedure First, Then GAE Procedure', 'description': 'Patients will be randomized to a sham procedure.\n\nSham Procedure: Patients will receive a sham procedure, which will include a diagnostic angiogram\n\nIf after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure\n\nGeniculate Artery Embolization: Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.9', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '62.9', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants have the same baseline characteristics.'}, {'title': 'WOMAC', 'classes': [{'title': 'Baseline for study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.9', 'spread': '16.6', 'groupId': 'BG000'}, {'value': '70.9', 'spread': '13.1', 'groupId': 'BG001'}, {'value': '66.6', 'spread': '14.4', 'groupId': 'BG002'}]}]}, {'title': 'Baseline Following Sham Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65.9', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '65.9', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC) will be used to measure function. This is a score derived from a questionnaire in which the patient answers questions regarding rheumatic symptoms in the subcategories of pain (5 items), stiffness (2 items), and physical function (17 items). Individuals select the level of difficulty they have performing various tasks using a 5 point Likert scale (0=None, 1=Slightly, 3=Very, 4=Extremely). Then, results are scored with a total score (minimum 0; maximum 96). A higher score indicates more difficulty in each of the categories.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All patients in the sham arm crossed over to receive the GAE procedure. Their baseline scores following the sham procedure are summarized in a separate row. Participants that had the GAE procedure to start are not crossed over.'}, {'title': 'VAS', 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13.9', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '15.4', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '14.3', 'spread': '3.1', 'groupId': 'BG002'}]}]}, {'title': 'baseline following sham procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '14', 'spread': '2.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain will be assessed at each of the patient\'s follow-up visits and used to measure the change from baseline (prior to the GAE procedure). The investigators will use this to measure if the patient\'s pain level decreases.', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All patients in the sham arm crossed over to receive the GAE procedure. Their baseline scores following the sham procedure are summarized in a separate row. Participants that had the GAE procedure to start are not crossed over.'}], 'populationDescription': 'All participants in the sham arm crossed over into the crossover arm so the sham participants and crossover participants are the same baseline characteristics except the VAS and WOMAC where they had new baseline scores following the sham procedure.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-16', 'size': 862075, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-19T17:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This will be a single-blinded randomized-controlled study of GAE versus placebo in a small population with knee pain secondary to arthritis to determine safety and efficacy. The placebo procedure will be a diagnostic angiogram of the knee, without embolization. Appropriate measures will be taken to ensure patients and nursing staff caring for the patient are blinded to assignment. Each patient will be told at the time of recruitment that they may be randomly assigned to sham, but if after 1 month they have not had symptom improvement, their assigned procedure would be revealed and, if they had undergone a sham procedure, they will be allowed to proceed with embolization.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-18', 'studyFirstSubmitDate': '2017-11-29', 'resultsFirstSubmitDate': '2021-01-27', 'studyFirstSubmitQcDate': '2017-11-29', 'lastUpdatePostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-19', 'studyFirstPostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Patient With Complications', 'timeFrame': '6 months following procedure for the "GAE Procedure" and "Crossover Arm" Arms/Groups and 1 month following procedure for the "Sham Procedure" Arm/Group', 'description': 'The number and description of complications, adverse events, or poor outcomes (such as no improvement in pain) that are secondary to the GAE procedure, which will be summarized using counts.'}], 'primaryOutcomes': [{'measure': 'Mean WOMAC Scores at Month 6', 'timeFrame': '6 months following procedure', 'description': 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC) will be used to measure function. This is a score derived from a questionnaire in which the patient answers questions regarding rheumatic symptoms in the subcategories of pain (5 items), stiffness (2 items), and physical function (17 items). Individuals select the level of difficulty they have performing various tasks using a 5 point Likert scale (0=None, 1=Slightly, 3=Very, 4=Extremely). Then, results are scored with a total score (minimum 0; maximum 96). A higher score indicates more difficulty in each of the categories.'}, {'measure': 'Mean Patient Pain as Measured by VAS at Month 6', 'timeFrame': '6 months following procedure', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain will be assessed at each of the patient\'s follow-up visits and used to measure the change from baseline (prior to the GAE procedure). The investigators will use this to measure if the patient\'s pain level decreases.'}, {'measure': 'Mean WOMAC Scores at Month 1', 'timeFrame': '1 month following procedure', 'description': 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC) will be used to measure function. This is a score derived from a questionnaire in which the patient answers questions regarding rheumatic symptoms in the subcategories of pain (5 items), stiffness (2 items), and physical function (17 items). Individuals select the level of difficulty they have performing various tasks using a 5 point Likert scale (0=None, 1=Slightly, 3=Very, 4=Extremely). Then, results are scored with a total score (minimum 0; maximum 96). A higher score indicates more difficulty in each of the categories.'}, {'measure': 'Mean Patient Pain as Measured by VAS at Month 1', 'timeFrame': '1 month following procedure', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain will be assessed at each of the patient\'s follow-up visits and used to measure the change from baseline (prior to the GAE procedure). The investigators will use this to measure if the patient\'s pain level decreases.'}, {'measure': 'Mean WOMAC Scores at Month 3', 'timeFrame': '3 months following procedure', 'description': 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC) will be used to measure function. This is a score derived from a questionnaire in which the patient answers questions regarding rheumatic symptoms in the subcategories of pain (5 items), stiffness (2 items), and physical function (17 items). Individuals select the level of difficulty they have performing various tasks using a 5 point Likert scale (0=None, 1=Slightly, 3=Very, 4=Extremely). Then, results are scored with a total score (minimum 0; maximum 96). A higher score indicates more difficulty in each of the categories.'}, {'measure': 'Mean Patient Pain as Measured by VAS at Month 3', 'timeFrame': '3 months following procedure', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain will be assessed at each of the patient\'s follow-up visits and used to measure the change from baseline (prior to the GAE procedure). The investigators will use this to measure if the patient\'s pain level decreases.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Reduction in Medication', 'timeFrame': '12 months following procedure', 'description': 'Reduction in the number or strength of previously initiated OA medical therapy (e.g. NSAIDs) at 6 months follow-up, which will be summarized using counts.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['embolization', 'vascular'], 'conditions': ['Osteo Arthritis Knee']}, 'descriptionModule': {'briefSummary': 'Purpose: To evaluate embolization as a treatment for OA related knee pain versus placebo to demonstrate the actual effect of embolization on pain and disability.\n\nParticipants: There will be 21 subjects enrolled over the age 40 with knee pain secondary to arthritis.\n\nProcedures (methods): This will be a single-blinded randomized-controlled study of GAE versus placebo in a small population with knee pain secondary to arthritis to determine safety and efficacy. Clinical procedures and evaluations will consist of a preoperative screening assessment to determine if the potential study subject meets the inclusion and exclusion criteria, enrollment, surgical procedure for geniculate artery embolization, and follow-up visits at 24 hours, 2 weeks, 1, 3, 6, \\& 12 months. An MRI may be performed after the 1-month visit.', 'detailedDescription': 'This will be a single-blinded randomized-controlled study of GAE versus placebo in a small population with knee pain secondary to arthritis to determine safety and efficacy. After Institutional Review Board (IRB) approval of a written informed consent and over, approximately a 24 month duration, N=21 subjects will be recruited. Only subjects ≥ 40 years will be screened for study recruitment. Subjects will be randomized in a 2:1 ratio of GAE:Placebo and will be blinded from study treatment (see flow chart below). The placebo procedure will be a diagnostic angiogram of the knee, without embolization. Appropriate measures will be taken to ensure patients and nursing staff caring for the patient are blinded to assignment. Each patient will be told at the time of recruitment that they may be randomly assigned to sham, but if after 1 month they have not had symptom improvement, their assigned procedure would be revealed and, if they had undergone a sham procedure, they will be allowed to proceed with embolization. This second procedure should be shorter than a complete angiogram and embolization, as the detailed angiogram will not need to be repeated, and therefore both arms will have similar total radiation dose.\n\nClinical procedures and evaluations will consist of a preoperative screening assessment to determine if the potential study subject meets the inclusion and exclusion criteria, enrollment, surgical procedure for geniculate artery embolization, and follow-up visits at 24 hours, 2 weeks, 1, 3, 6, \\& 12 months. An MRI may be performed after the 1-month visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nModerate to severe knee pain (visual analog scale (VAS) \\> 50 mm), and Pain refractory to at least 3 months\\* of conservative therapies (anti- inflammatory drugs, or physical therapy, or muscle strengthening, or intra- articular injections), and Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee.\n\nExclusion Criteria:\n\nCurrent local infection, or Life expectancy less than 6 months, or Known advanced atherosclerosis, or Rheumatoid or infectious arthritis, or Prior knee surgery, or Uncorrectable coagulopathy including international normalized ratio (INR) \\> 2.5 or platelets \\< 30,000, or Iodine allergy resulting in anaphylaxis, or Renal dysfunction as defined by serum creatinine \\>1.6 dl/mg or estimated glomerular filtration rate (eGFR) \\<60 obtained within the past 30 days.'}, 'identificationModule': {'nctId': 'NCT03362957', 'briefTitle': 'Geniculate Artery Embolization for Knee Pain Secondary to Osteoarthritis (OA)', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Randomized Placebo-Controlled Single Blinded Study of Geniculate Artery Embolization for Knee Pain Secondary to Osteoarthritis', 'orgStudyIdInfo': {'id': '17-2701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GAE Procedure', 'description': 'Patients will be randomized to receive the Geniculate Artery Embolization Procedure', 'interventionNames': ['Device: Geniculate Artery Embolization']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Procedure', 'description': 'Patients will be randomized to a sham procedure.', 'interventionNames': ['Diagnostic Test: Sham Procedure']}, {'type': 'EXPERIMENTAL', 'label': 'Crossover Arm', 'description': 'If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure', 'interventionNames': ['Device: Geniculate Artery Embolization']}], 'interventions': [{'name': 'Geniculate Artery Embolization', 'type': 'DEVICE', 'description': 'Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.', 'armGroupLabels': ['Crossover Arm', 'GAE Procedure']}, {'name': 'Sham Procedure', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will receive a sham procedure, which will include a diagnostic angiogram', 'armGroupLabels': ['Sham Procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Hospitals', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '22193', 'city': 'Woodbridge', 'state': 'Virginia', 'country': 'United States', 'facility': 'Vascular Institute of Virginia', 'geoPoint': {'lat': 38.65817, 'lon': -77.2497}}], 'overallOfficials': [{'name': 'Ari Isaacson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}