Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-29 @ 10:52 AM
Study NCT ID:
NCT01628159
Status:
COMPLETED
Last Update Posted:
2020-04-10
First Post:
2012-06-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LEVANT 2 Continuation Registry of the Lutonix® Drug Coated Balloon (DCB)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anna.lovas@bd.com', 'phone': '763-445-2385', 'title': 'Director of Clinical Affairs', 'organization': 'BD'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Post Index Procedure to End of Follow up Period (5-Year visit window).', 'description': 'All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related.\n\nAll non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events.\n\nThe number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter\n\nLutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon', 'otherNumAtRisk': 657, 'deathsNumAtRisk': 657, 'otherNumAffected': 528, 'seriousNumAtRisk': 657, 'deathsNumAffected': 83, 'seriousNumAffected': 67}], 'otherEvents': [{'term': 'Arrhytmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 36, 'numAffected': 34}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 50, 'numAffected': 43}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Other cardiovascular events', 'notes': 'Cardiovascular events, not specified. Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 87, 'numAffected': 67}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Gastrointestinal events (other)', 'notes': 'Gastrointestinal events, not specified. Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 128, 'numAffected': 79}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Local Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 69, 'numAffected': 52}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Neurological events (other)', 'notes': 'Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 64, 'numAffected': 54}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Respiratory (other)', 'notes': 'Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 67, 'numAffected': 52}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 72, 'numAffected': 67}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 59, 'numAffected': 55}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Skeletal, spine and muscular events (Other)', 'notes': 'Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 241, 'numAffected': 155}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Restenosis', 'notes': 'Target Lesion: Restenosis event.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 36, 'numAffected': 35}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Renal failure/ insufficiency', 'notes': 'Genito-urinary system event.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 37, 'numAffected': 35}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Urinary infection', 'notes': 'Genito-urinary system event.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 65, 'numAffected': 46}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Various', 'notes': 'Not otherwise described. Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 527, 'numAffected': 241}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Vessel specific events (Other)', 'notes': 'Vessel specific events in the leg (not target lesion or target vessel). Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 44, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}], 'seriousEvents': [{'term': 'Infection, local', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Infection (systemic)', 'notes': 'Infection (systemic) requiring antibiotics.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Significant hemorrhage', 'notes': 'Access site: Significant hemorrhagic event requiring transfusion.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Pseudoaneurysm', 'notes': 'Access site: Pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Target vessel injury', 'notes': 'Angiographic event: Target vessel injury:/dissection with study treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Distal embolization with study treatment', 'notes': 'Angiographic event.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Distal embolization with post treatment', 'notes': 'Angiographic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Clot/Thrombus formation', 'notes': 'Angiographic event: Thrombosis.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Other angiographic event', 'notes': 'Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Restenosis of study lesion', 'notes': 'Vascular event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Clinically-driven Target Lesion Revascularization', 'notes': 'Vascular event: Clinically-driven target (study) lesion revascularization (TLR)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Target (study) vessel revascularization (TVR)', 'notes': 'Vascular event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Target (study) limb ishchemia', 'notes': 'Vascular event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Other vascular event', 'notes': 'Not specified. Events in this category were not collected in a way that allows their separation into specific categories or by specific events terms.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}, {'term': 'Claudication', 'notes': 'Vascular event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Internal System'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Unanticipated Device- or Drug- Related Adverse Events Through 60 Months Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter\n\nLutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 months Post Index Procedure', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 1, 6, 12, 24, 36, 48, and 60 Months Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter\n\nLutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon'}], 'classes': [{'title': '1 Month Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '638', 'groupId': 'OG000'}]}]}, {'title': '6 months post-index procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '596', 'groupId': 'OG000'}]}]}, {'title': '12 months post Index procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '525', 'groupId': 'OG000'}]}]}, {'title': '24 Months Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '434', 'groupId': 'OG000'}]}]}, {'title': '36 Months Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '568', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '385', 'groupId': 'OG000'}]}]}, {'title': '48 Months Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '547', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '347', 'groupId': 'OG000'}]}]}, {'title': '60 Months Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '529', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '320', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1, 6, 12, 24, 36, 48 and 60 months Post Index Procedure', 'description': 'Composite of freedom from all-cause perioperative (≤ 30 day) death and freedom from the following at 1, 6, 12, 24, 36, 48, and 60 months: index limb amputation, index limb re-intervention, and index-limb-related death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Acute Device Success at Time of Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}]}, {'units': 'Devices', 'counts': [{'value': '894', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter\n\nLutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon'}], 'classes': [{'categories': [{'measurements': [{'value': '894', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'At time of Index Procedure', 'description': 'In certain procedures, more than one device was use resulting in a higher number of devices (894) than participants (657) for this endpoint.', 'unitOfMeasure': 'Devices', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Devices', 'denomUnitsSelected': 'Devices'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Freedom From All-cause Death, Index Limb Amputation Above the Ankle and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '647', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter\n\nLutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon'}], 'classes': [{'categories': [{'measurements': [{'value': '642', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post index procedure', 'description': 'This VIVA Safety Endpoint is defined as Freedom at 30 days from all-cause death, index limb amputation above the ankle and target vessel revascularization (TVR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 1, 6, 12, 24, 36, 48, and 60 Months Post Index Procedure (PPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter\n\nLutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon'}], 'classes': [{'title': 'Death : 1 month PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '647', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Death : 6 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '636', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Death : 12 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '626', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Death : 24 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '601', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Death : 36 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Death : 48 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Death : 60 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '573', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'Major Amputation : 1 month PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '646', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Major Amputation : 6 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Major Amputation : 12 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '620', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Major Amputation : 24 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Major Amputation : 36 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '557', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Major Amputation : 48 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Major Amputation : 60 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Minor Amputation : 1 month PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '646', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Minor Amputation : 6 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Minor Amputation : 12 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '620', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Minor Amputation : 24 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Minor Amputation : 36 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '556', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Minor Amputation : 48 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '523', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Minor Amputation : 60 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Amputation Free Survival 1 month PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '647', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '646', 'groupId': 'OG000'}]}]}, {'title': 'Amputation Free Survival : 6 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '636', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '632', 'groupId': 'OG000'}]}]}, {'title': 'Amputation Free Survival : 12 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '626', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '618', 'groupId': 'OG000'}]}]}, {'title': 'Amputation Free Survival : 24 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '602', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '580', 'groupId': 'OG000'}]}]}, {'title': 'Amputation Free Survival : 36 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '593', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '547', 'groupId': 'OG000'}]}]}, {'title': 'Amputation Free Survival : 48 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '515', 'groupId': 'OG000'}]}]}, {'title': 'Amputation Free Survival : 60 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '575', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '487', 'groupId': 'OG000'}]}]}, {'title': 'Total TLR : 1 month PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '646', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Total TLR : 6 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Total TLR : 12 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '621', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}, {'title': 'Total TLR : 24 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}]}]}, {'title': 'Total TLR : 36 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '565', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}]}]}, {'title': 'Total TLR : 48 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '540', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}]}]}, {'title': 'Total TLR : 60 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '520', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}]}]}, {'title': 'Total TVR : 1 month PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '646', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Total TVR : 6 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Total TVR : 12 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '621', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'Total TVR : 24 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}]}]}, {'title': 'Total TVR : 36 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '565', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}]}]}, {'title': 'Total TVR : 48 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '542', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000'}]}]}, {'title': 'Total TVR : 60 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '523', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}]}]}, {'title': 'Reintervention Thrombosis1 month PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '646', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Reintervention Thrombosis : 6 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ReinterventionThrombosis : 12 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '620', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Reintervention Thrombosis : 24 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'ReinterventionThrombosis : 36 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '557', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Reintervention Thrombosis : 48 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '523', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'ReinterventionThrombosis : 60 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Cardiovascular Hospitalization : 1 month PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '647', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Cardiovascular Hospitalization : 6 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '634', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Cardiovascular Hospitalization : 12 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Cardiovascular Hospitalization : 24 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Cardiovascular Hospitalization : 36 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '565', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Cardiovascular Hospitalization : 48 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Cardiovascular Hospitalization : 60 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Major Vascular Complication : 1 month PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '648', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Major Vascular Complication : 6 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '635', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Major Vascular Complication : 12 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Major Vascular Complication : 24 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Major Vascular Complication : 36 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '567', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Major Vascular Complication : 48 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': 'Major Vascular Complication : 60 months PPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '513', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 6, 12, 24, 36, 48, and 60 months post index procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Technical and Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter\n\nLutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon'}], 'classes': [{'title': 'Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '644', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '566', 'groupId': 'OG000'}]}]}, {'title': 'Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '644', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '565', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of index procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Primary Patency of the Target at 6, 12, and 24 Months Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter\n\nLutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon'}], 'classes': [{'title': '6 months post index procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '483', 'groupId': 'OG000'}]}]}, {'title': '12 months post index procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '386', 'groupId': 'OG000'}]}]}, {'title': '24 months post index procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '547', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '298', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6, 12, and 24 months post index procedure', 'description': 'Primary patency is defined as freedom from target lesion restenosis by core lab adjudication (DUS ≥ 2.5) and target lesion revascularization (TLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter\n\nLutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon'}], 'classes': [{'title': '6 months post index procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '572', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.27', 'groupId': 'OG000'}]}]}, {'title': '12 months post index procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.27', 'groupId': 'OG000'}]}]}, {'title': 'At 24 months post index procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '484', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6, 12, and 24 months post index procedure', 'description': 'Presented is a summary of the Mean change in resting Ankle Brachial Index (ABI) from baseline through 24 months post index procedure. The ABI is defined as a ratio of ankle to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs. A lower ABI number suggests more Peripheral Arterial Disease.', 'unitOfMeasure': 'Index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter\n\nLutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon'}], 'classes': [{'title': '1 month post index procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '646', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '643', 'groupId': 'OG000'}]}]}, {'title': '6 months post index procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '611', 'groupId': 'OG000'}]}]}, {'title': '12 months post index procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '621', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '543', 'groupId': 'OG000'}]}]}, {'title': '24 months post index proceedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '456', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1, 6, 12, and 24 months post index procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.'}, {'type': 'SECONDARY', 'title': 'Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter\n\nLutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon'}], 'classes': [{'title': '6 months from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improved', 'measurements': [{'value': '540', 'groupId': 'OG000'}]}, {'title': 'Same', 'measurements': [{'value': '49', 'groupId': 'OG000'}]}, {'title': 'Worsened', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': '12 months from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '581', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improved', 'measurements': [{'value': '498', 'groupId': 'OG000'}]}, {'title': 'Same', 'measurements': [{'value': '62', 'groupId': 'OG000'}]}, {'title': 'Worsened', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': '24 months from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improved', 'measurements': [{'value': '459', 'groupId': 'OG000'}]}, {'title': 'Same', 'measurements': [{'value': '57', 'groupId': 'OG000'}]}, {'title': 'Worsened', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6, 12, and 24 months post index procedure', 'description': 'The endpoint summarizes the change in index-limb Rutherford Classification of participants from baseline through 24 months. Data is presented as shift from baseline Rutherford Classification data using the following categories: 1) Improvement, 2) Same, and 3) Worsened.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter\n\nLutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon'}], 'classes': [{'title': 'DUS PSVR >= 3.0 : 6 months post index procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '479', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '411', 'groupId': 'OG000'}]}]}, {'title': 'DUS PSVR >= 3.0 : 12 months post index procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '295', 'groupId': 'OG000'}]}]}, {'title': 'DUS PSVR >= 3.0 : 24 months post index procdure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}]}]}, {'title': 'DUS PSVR >= 2.5 : 6 months post index procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '475', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '396', 'groupId': 'OG000'}]}]}, {'title': 'DUS PSVR >= 2.5 : 12 months post index procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '289', 'groupId': 'OG000'}]}]}, {'title': 'DUS PSVR >= 2.5 : 24 months post index procdure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '203', 'groupId': 'OG000'}]}]}, {'title': 'DUS PSVR >= 2.0 : 6 months post index procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '345', 'groupId': 'OG000'}]}]}, {'title': 'DUS PSVR >= 2.0 : 12 months post index procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '242', 'groupId': 'OG000'}]}]}, {'title': 'DUS PSVR >= 2.0 : 24 months post index procdure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '454', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6, 12, and 24 months post index procedure', 'description': '* Alternative Primary and Secondary Patency based on alternative definitions of Duplex Ultrasonography (DUS) Peak Systolic Velocity Ratio (PSVR) \\<2.0 and \\<3.0\n* Duplex Ultrasonography (DUS) Clinical Patency (DUS Peak Systolic Velocity Ratio (PSVR) \\<2.5 without prior Clinically Driven TLR)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter\n\nLutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '657'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '493'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter\n\nLutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.7', 'spread': '9.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '238', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '419', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '645', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '657', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Rutherford Classification', 'classes': [{'title': 'Rutherford 0', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Rutherford 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Rutherford 2', 'categories': [{'measurements': [{'value': '240', 'groupId': 'BG000'}]}]}, {'title': 'Rutherford 3', 'categories': [{'measurements': [{'value': '379', 'groupId': 'BG000'}]}]}, {'title': 'Rutherford 4', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}, {'title': 'Rutherford 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Rutherford 6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Rutherford Classification is on an ascending scale from 0 to 6. Lower classifications on the scale indicate more favorable outcomes.\n\n0 - Asymptomatic\n\n1. \\- Mild claudication\n2. \\- Moderate claudication\n3. \\- Severe claudication\n4. \\- Rest pain\n5. \\- Ischemic ulceration not exceeding ulcer of the digits of the foot\n6. \\- Sever ischemic ulcers or frank gangrene', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-03-26', 'size': 676834, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-13T15:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 657}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-31', 'studyFirstSubmitDate': '2012-06-19', 'resultsFirstSubmitDate': '2020-03-16', 'studyFirstSubmitQcDate': '2012-06-25', 'lastUpdatePostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-31', 'studyFirstPostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Unanticipated Device- or Drug- Related Adverse Events Through 60 Months Post Index Procedure', 'timeFrame': '60 months Post Index Procedure'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 1, 6, 12, 24, 36, 48, and 60 Months Post Index Procedure', 'timeFrame': '1, 6, 12, 24, 36, 48 and 60 months Post Index Procedure', 'description': 'Composite of freedom from all-cause perioperative (≤ 30 day) death and freedom from the following at 1, 6, 12, 24, 36, 48, and 60 months: index limb amputation, index limb re-intervention, and index-limb-related death.'}, {'measure': 'Number of Acute Device Success at Time of Index Procedure', 'timeFrame': 'At time of Index Procedure', 'description': 'In certain procedures, more than one device was use resulting in a higher number of devices (894) than participants (657) for this endpoint.'}, {'measure': 'Number of Participants With Freedom From All-cause Death, Index Limb Amputation Above the Ankle and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure', 'timeFrame': '30 days post index procedure', 'description': 'This VIVA Safety Endpoint is defined as Freedom at 30 days from all-cause death, index limb amputation above the ankle and target vessel revascularization (TVR).'}, {'measure': 'Number of Participants With Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 1, 6, 12, 24, 36, 48, and 60 Months Post Index Procedure (PPI)', 'timeFrame': '1, 6, 12, 24, 36, 48, and 60 months post index procedure'}, {'measure': 'Number of Participants With Technical and Procedural Success', 'timeFrame': 'At time of index procedure'}, {'measure': 'Number of Participants With Primary Patency of the Target at 6, 12, and 24 Months Post Index Procedure', 'timeFrame': '6, 12, and 24 months post index procedure', 'description': 'Primary patency is defined as freedom from target lesion restenosis by core lab adjudication (DUS ≥ 2.5) and target lesion revascularization (TLR).'}, {'measure': 'Change From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Post Index Procedure', 'timeFrame': '6, 12, and 24 months post index procedure', 'description': 'Presented is a summary of the Mean change in resting Ankle Brachial Index (ABI) from baseline through 24 months post index procedure. The ABI is defined as a ratio of ankle to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs. A lower ABI number suggests more Peripheral Arterial Disease.'}, {'measure': 'Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure', 'timeFrame': '1, 6, 12, and 24 months post index procedure'}, {'measure': 'Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure', 'timeFrame': '6, 12, and 24 months post index procedure', 'description': 'The endpoint summarizes the change in index-limb Rutherford Classification of participants from baseline through 24 months. Data is presented as shift from baseline Rutherford Classification data using the following categories: 1) Improvement, 2) Same, and 3) Worsened.'}, {'measure': 'Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure', 'timeFrame': '6, 12, and 24 months post index procedure', 'description': '* Alternative Primary and Secondary Patency based on alternative definitions of Duplex Ultrasonography (DUS) Peak Systolic Velocity Ratio (PSVR) \\<2.0 and \\<3.0\n* Duplex Ultrasonography (DUS) Clinical Patency (DUS Peak Systolic Velocity Ratio (PSVR) \\<2.5 without prior Clinically Driven TLR)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Peripheral Artery Disease']}, 'referencesModule': {'references': [{'pmid': '31575518', 'type': 'DERIVED', 'citation': 'Ouriel K, Adelman MA, Rosenfield K, Scheinert D, Brodmann M, Pena C, Geraghty P, Lee A, White R, Clair DG. Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2515-2524. doi: 10.1016/j.jcin.2019.08.025. Epub 2019 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.', 'detailedDescription': 'The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries through 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Clinical Inclusion Criteria:\n\n1. Male or non-pregnant female ≥18 years of age;\n2. Rutherford Clinical Category 2-4;\n3. Patient is willing to provide informed consent, is geographically stable and comply with the required follow up visits, testing schedule and medication regimen;\n\n Angiographic Lesion Inclusion Criteria:\n4. Length ≤15 cm;\n5. Up to two focal lesions or segments within the designated 15 cm length of vessel may be treated (e.g. two discrete segments, separated by several cm, but both falling within a composite length of \\<15 cm);\n6. ≥70% stenosis by visual estimate;\n7. Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk;\n8. de novo lesion(s) or non-stented restenotic lesion(s) \\>90 days from prior angioplasty procedure;\n9. Lesion is located at least 3 cm from any stent, if target vessel was previously stented;\n10. Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix;\n11. Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion;\n12. A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow artery lesions); NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication.\n13. At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been revascularized (treatment of outflow disease is NOT permitted during the index procedure);\n14. Contralateral limb lesion(s) cannot be treated within 2 weeks before and/or planned 30 days after the protocol treatment in order to avoid confounding complications;\n15. No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment.\n\nExclusion Criteria:\n\nPatients will be excluded if ANY of the following conditions apply:\n\n1. Pregnant or planning on becoming pregnant or men intending to father children;\n2. Life expectancy of \\<5 years;\n3. Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in another clinical trial during the follow up period is not allowed.\n4. History of hemorrhagic stroke within 3 months;\n5. Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;\n6. History of MI, thrombolysis or angina within 2 weeks of enrollment;\n7. Rutherford Class 0, 1, 5 or 6;\n8. Renal failure or chronic kidney disease with MDRD GFR ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis);\n9. Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;\n10. Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;\n11. Anticipated use of IIb/IIIa inhibitor prior to randomization;\n12. Ipsilateral retrograde access;\n13. Composite lesion length is \\>15 cm or there is no normal proximal arterial segment in which duplex flow velocity can be measured;\n14. Significant inflow disease. Successful treatment of inflow disease allowed prior to target lesion treatment;\n15. Known inadequate distal outflow (\\>50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion;\n16. Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel;\n17. Severe calcification that renders the lesion un-dilatable;\n18. Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.).'}, 'identificationModule': {'nctId': 'NCT01628159', 'briefTitle': 'LEVANT 2 Continuation Registry of the Lutonix® Drug Coated Balloon (DCB)', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'A Prospective, Multicenter, LEVANT 2 Continuation Registry of the Moxy™ Drug Coated Balloon for Treatment of Femoropopliteal Arteries', 'orgStudyIdInfo': {'id': 'CL0002-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lutonix Drug Coated Balloon', 'description': 'Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter', 'interventionNames': ['Device: Lutonix Drug Coated Balloon']}], 'interventions': [{'name': 'Lutonix Drug Coated Balloon', 'type': 'DEVICE', 'otherNames': ['Moxy Drug Coated Balloon'], 'description': 'balloon angioplasty with a drug coated balloon', 'armGroupLabels': ['Lutonix Drug Coated Balloon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'North County Radiology Medial Group Inc.', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "St. Joseph's Hospital", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80538', 'city': 'Loveland', 'state': 'Colorado', 'country': 'United States', 'facility': 'Medical Center of the Rockies', 'geoPoint': {'lat': 40.39776, 'lon': -105.07498}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Cardiology Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Heart and Vascular Institute', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Interventional Cardiolgists of Gainesville', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Munroe Regional Medical Center', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '60007', 'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cardiovascular Associates', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Christ Medical Center', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '60181', 'city': 'Oakbrook Terrace', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Heart / Midwest Research Foundation', 'geoPoint': {'lat': 41.85003, 'lon': -87.96451}}, {'zip': '62710', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': "St. John's Hosptial", 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46802', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Allen County Cardiology', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46290', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Vincent Heart Center of Indianapolis', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '67502', 'city': 'Hutchinson', 'state': 'Kansas', 'country': 'United States', 'facility': 'Promise Regional Medical Center', 'geoPoint': {'lat': 38.06084, 'lon': -97.92977}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'St. Francis Heart & Vascular Center', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Genearl Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Detroit Medical Center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48236', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "St. John's Hospital", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48197', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Heart', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}, {'zip': '55433', 'city': 'Coon Rapids', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mercy Hosptial', 'geoPoint': {'lat': 45.11997, 'lon': -93.28773}}, {'zip': '39401', 'city': 'Hattiesburg', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Forrest General Hospital', 'geoPoint': {'lat': 31.32712, 'lon': -89.29034}}, {'zip': '08015', 'city': 'Browns Mills', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Deborah Heart and Lung Center', 'geoPoint': {'lat': 39.97261, 'lon': -74.58293}}, {'zip': '08034', 'city': 'Cherry Hill', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Our Lady of Lourdes Medical Center', 'geoPoint': {'lat': 39.93484, 'lon': -75.03073}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia Universtiy Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27610', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Heart and Vascular', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Christ Hospital / The Lindner Clinical Trial Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mid Ohio Cardiology and Vascular Consultants', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Jobst Vascular Institute', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '43614', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Univesrity of Toledo Medical Center', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Memorial Hospital', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Wellmont Cardiology Services', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '37934', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'East Tennessee Heart Consultants', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Heart P.A.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': 'A-8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Klagenfurt', 'country': 'Austria', 'facility': 'Klinikum Klagenfurt', 'geoPoint': {'lat': 46.62472, 'lon': 14.30528}}, {'city': 'Aalst', 'country': 'Belgium', 'facility': 'OLV Ziekenhuis', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Imelda Ziekenhuis', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'city': 'Dendermonde', 'country': 'Belgium', 'facility': 'Flanders Medical Research Program', 'geoPoint': {'lat': 51.02869, 'lon': 4.10106}}, {'city': 'Genk', 'country': 'Belgium', 'facility': 'Hospital Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'Herz-Zentrum', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Jewish Hospital', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Flensburg', 'country': 'Germany', 'facility': 'Diakonissenanstalt zu Flensburg', 'geoPoint': {'lat': 54.78805, 'lon': 9.43722}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Hamburg University Cardiovascular Center', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'University Clinical Center Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Immenstadt im Allgäu', 'country': 'Germany', 'facility': 'Herz-Und Gefasszentrum', 'geoPoint': {'lat': 47.55996, 'lon': 10.21394}}, {'city': 'Kaiserslautern', 'country': 'Germany', 'facility': 'Practice for Interventional Radiology', 'geoPoint': {'lat': 49.443, 'lon': 7.77161}}, {'city': 'Kusen', 'country': 'Germany', 'facility': 'Westpfalz Clinic'}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'University Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Magdeburg', 'country': 'Germany', 'facility': 'University Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'University of Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'Universtiy Clinic Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Potstdam', 'country': 'Germany', 'facility': 'Ernst von Bergham Clinic'}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'University of Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Lucerne', 'country': 'Switzerland', 'facility': 'Canton Hospital Lucerne', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital, Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Kenneth Rosenfield, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Prof. Dierk Scheinert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Leipzig'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not at this time.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. R. Bard', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}