Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-11 @ 1:43 PM
Study NCT ID:
NCT01537302
Status:
COMPLETED
Last Update Posted:
2021-03-22
First Post:
2012-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II
Sponsor:
Organization:
Raw JSON
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IN shall delay publication/presentation to enable SP to secure patent or other proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 0 through Day 30', 'eventGroups': [{'id': 'EG000', 'title': 'Ocelot System', 'description': 'CTO crossing in femoropopliteal arteries using the Ocelot System', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 25, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Bruising or hemorrhage at procedural access site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding, other than access site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain, new or worsening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Perforation not requiring intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel dissection, Grade A or B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel dissection, Grade C or greater', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AV fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'AV Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel Dissection, Grade C or greater', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel Dissection, Grade A or B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising or hemorrhage at procedural access site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain, new or worsening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding (other than access site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension, sustained', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Perforation requiring intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Perforation, not requiring intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute COPD exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'limb ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction to contrast medium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Altered mental state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg ulcerations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intractable nausea/vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Uncontrolled hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Safety Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocelot System', 'description': 'CTO crossing in femoropopliteal arteries using the Ocelot System'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'comment': 'This is a 95% one-sided confidence interval.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '6.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30', 'description': 'No evidence of in-hospital MAEs, 30 day MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Ocelot System CTO crossing confirmed by angiography.', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Two subjects withdrew prior to 30-day follow-up.'}, {'type': 'PRIMARY', 'title': 'Primary Efficacy Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocelot System', 'description': 'CTO crossing in femoropopliteal arteries using the Ocelot System'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'description': 'Successful femoropopliteal CTO crossing using the Ocelot System as identified by guidewire placement in the distal true lumen confirmed by angiography.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocelot System', 'description': 'CTO crossing in femoropopliteal arteries using the Ocelot System'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'description': 'Successful delivery, crossing and retrieval of the investigational device in the absence of in-hospital MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocelot System', 'description': 'CTO crossing in femoropopliteal arteries using the Ocelot System'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'description': 'Successful delivery, crossing and retrieval of the investigational device without the use of an assist device.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Device Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocelot System', 'description': 'CTO crossing in femoropopliteal arteries using the Ocelot System'}], 'classes': [{'title': 'Catheter Performance Evaluation: Introduction into sheath', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'title': '5 - Excellent', 'measurements': [{'value': '87', 'groupId': 'OG000'}]}, {'title': '4 - Good', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': '3 - Acceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '2 - Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1 - Unacceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Catheter Performance Evaluation: Catheter trackability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'title': '5 - Excellent', 'measurements': [{'value': '76', 'groupId': 'OG000'}]}, {'title': '4 - Good', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': '3 - Acceptable', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '2 - Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1 - Unacceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Catheter Performance Evaluation: Catheter pushability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'title': '5 - Excellent', 'measurements': [{'value': '62', 'groupId': 'OG000'}]}, {'title': '4 - Good', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}, {'title': '3 - Acceptable', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': '2 - Poor', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '1 - Unacceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Catheter Performance Evaluation: Tip Deflection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'title': '5 - Excellent', 'measurements': [{'value': '56', 'groupId': 'OG000'}]}, {'title': '4 - Good', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': '3 - Acceptable', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': '2 - Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1 - Unacceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Catheter Performance Evaluation: Ability to stay in true lumen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'title': '5 - Excellent', 'measurements': [{'value': '65', 'groupId': 'OG000'}]}, {'title': '4 - Good', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': '3 - Acceptable', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': '2 - Poor', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '1 - Unacceptable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Catheter Performance Evaluation: Visibility of radiopaque marker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'title': '5 - Excellent', 'measurements': [{'value': '82', 'groupId': 'OG000'}]}, {'title': '4 - Good', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': '3 - Acceptable', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '2 - Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1 - Unacceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Catheter Performance Evaluation: Catheter tip visibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'title': '5 - Excellent', 'measurements': [{'value': '84', 'groupId': 'OG000'}]}, {'title': '4 - Good', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': '3 - Acceptable', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '2 - Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1 - Unacceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'OCT Performance Evaluation: Clarity of images', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'title': '5 - Excellent', 'measurements': [{'value': '63', 'groupId': 'OG000'}]}, {'title': '4 - Good', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}, {'title': '3 - Acceptable', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '2 - Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1 - Unacceptable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'OCT Performance Evaluation: Visualization of layered structures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'title': '5 - Excellent', 'measurements': [{'value': '65', 'groupId': 'OG000'}]}, {'title': '4 - Good', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': '3 - Acceptable', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': '2 - Poor', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '1 - Unacceptable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'OCT Performance Evaluation: Visualization of non-layered structures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'title': '5 - Excellent', 'measurements': [{'value': '63', 'groupId': 'OG000'}]}, {'title': '4 - Good', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': '3 - Acceptable', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': '2 - Poor', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '1 - Unacceptable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'OCT Performance Evaluation: Visualization of side branches', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'title': '5 - Excellent', 'measurements': [{'value': '60', 'groupId': 'OG000'}]}, {'title': '4 - Good', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': '3 - Acceptable', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': '2 - Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1 - Unacceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'OCT Performance Evaluation: Flush adequately displaces blood for visualization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'title': '5 - Excellent', 'measurements': [{'value': '70', 'groupId': 'OG000'}]}, {'title': '4 - Good', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': '3 - Acceptable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '2 - Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1 - Unacceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'OCT Performance Evaluation: Ability to orient using the middle marker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'title': '5 - Excellent', 'measurements': [{'value': '65', 'groupId': 'OG000'}]}, {'title': '4 - Good', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': '3 - Acceptable', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': '2 - Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1 - Unacceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'OCT Performance Evaluation: Ability of OCT marker band to aid in catheter navigation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'title': '5 - Excellent', 'measurements': [{'value': '70', 'groupId': 'OG000'}]}, {'title': '4 - Good', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': '3 - Acceptable', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': '2 - Poor', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '1 - Unacceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'description': "Device performance as assessed by Investigator's input by evaluating both performance of the device and quality of the OCT image as it relates to the ability to identify layered and non-layered structures and the ability of the directional marker bands to aid in orientation of the catheter while advancing through the CTO.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "'Catheter Performance Evaluation: Tip Deflection': Data was missing for one subject for this question.\n\n'OCT Performance Evaluation: Visualization of side branches': N/A in 9 subjects who did not have side branches visualized."}, {'type': 'SECONDARY', 'title': 'Procedural Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocelot System', 'description': 'CTO crossing in femoropopliteal arteries using the Ocelot System'}], 'classes': [{'categories': [{'measurements': [{'value': '107.3', 'spread': '57.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Total time of the procedure from the insertion of the catheter to its removal following treatment of the CTO', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fluoroscopic Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocelot System', 'description': 'CTO crossing in femoropopliteal arteries using the Ocelot System'}], 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '29.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Total time fluoroscopy was used during the procedure.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CTO Crossing Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocelot System', 'description': 'CTO crossing in femoropopliteal arteries using the Ocelot System'}], 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'spread': '42.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Time required to cross the CTO during the procedure.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Use of Assist Devices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocelot System', 'description': 'CTO crossing in femoropopliteal arteries using the Ocelot System'}], 'classes': [{'title': 'CTO Crossing Time: Ocelot Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.8', 'spread': '18.4', 'groupId': 'OG000'}]}]}, {'title': 'CTO Crossing Time: Ocelot and assist devices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.1', 'spread': '58.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Comparison of the crossing times for the Ocelot System alone versus the Ocelot System with assist devices.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Seventy-two participants in the 'CTO Crossing Time: Ocelot Alone'. Twenty-five participants in the 'CTO Crossing Time: Ocelot and assist devices'. Three subjects who did not have their CTO successfully crossed were excluded from calculation."}, {'type': 'SECONDARY', 'title': 'Contrast/Flush Volumes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocelot System', 'description': 'CTO crossing in femoropopliteal arteries using the Ocelot System'}], 'classes': [{'title': 'Flush Volume (through Ocelot for visualization only)', 'categories': [{'measurements': [{'value': '33.1', 'spread': '57.9', 'groupId': 'OG000'}]}]}, {'title': 'Contrast Volume (used for entire procedure)', 'categories': [{'measurements': [{'value': '223.0', 'spread': '144.7', 'groupId': 'OG000'}]}]}, {'title': 'Contrast Volume (procedure start through CTO crossing)', 'categories': [{'measurements': [{'value': '124.5', 'spread': '100.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Contrast and flush volumes are presented', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ocelot System', 'description': 'CTO crossing in femoropopliteal arteries using the Ocelot System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients with CTO were approached to consider joining the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ocelot System', 'description': 'CTO crossing in femoropopliteal arteries using the Ocelot System'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '68.6', 'spread': '9.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}, {'title': 'African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic/Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'American Indian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data unknown for 12 subjects.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Rutherford', 'classes': [{'title': '0 - Asymptomatic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '1 - Mild Claudication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '2 - Moderate Claudication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': '3 - Severe Claudication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}, {'title': '4 - Ischemic Rest Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': '5 - Minor Tissue Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': '6 - Major Tissue Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ankle-Brachial Index', 'classes': [{'title': 'ABI >1.3: Non-Compressible Vessels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'ABI ≥ 0.95: Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'ABI < 0.95: Peripheral Vascular Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}, {'title': 'ABI < 0.6: Intermittent Claudication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}, {'title': 'ABI < 0.4: Chronic Limb Ischemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not obtained for 2 subjects.'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28.7', 'spread': '6.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All enrolled subjects.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-18', 'studyFirstSubmitDate': '2012-02-15', 'resultsFirstSubmitDate': '2015-03-05', 'studyFirstSubmitQcDate': '2012-02-22', 'lastUpdatePostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-03-17', 'studyFirstPostDateStruct': {'date': '2012-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety Endpoint', 'timeFrame': 'Day 30', 'description': 'No evidence of in-hospital MAEs, 30 day MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Ocelot System CTO crossing confirmed by angiography.'}, {'measure': 'Primary Efficacy Endpoint', 'timeFrame': 'Day 0', 'description': 'Successful femoropopliteal CTO crossing using the Ocelot System as identified by guidewire placement in the distal true lumen confirmed by angiography.'}], 'secondaryOutcomes': [{'measure': 'Procedural Success', 'timeFrame': 'Day 0', 'description': 'Successful delivery, crossing and retrieval of the investigational device in the absence of in-hospital MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections.'}, {'measure': 'Technical Success', 'timeFrame': 'Day 0', 'description': 'Successful delivery, crossing and retrieval of the investigational device without the use of an assist device.'}, {'measure': 'Device Performance', 'timeFrame': 'Day 0', 'description': "Device performance as assessed by Investigator's input by evaluating both performance of the device and quality of the OCT image as it relates to the ability to identify layered and non-layered structures and the ability of the directional marker bands to aid in orientation of the catheter while advancing through the CTO."}, {'measure': 'Procedural Time', 'timeFrame': 'Day 0', 'description': 'Total time of the procedure from the insertion of the catheter to its removal following treatment of the CTO'}, {'measure': 'Fluoroscopic Time', 'timeFrame': 'Day 0', 'description': 'Total time fluoroscopy was used during the procedure.'}, {'measure': 'CTO Crossing Time', 'timeFrame': 'Day 0', 'description': 'Time required to cross the CTO during the procedure.'}, {'measure': 'Use of Assist Devices', 'timeFrame': 'Day 0', 'description': 'Comparison of the crossing times for the Ocelot System alone versus the Ocelot System with assist devices.'}, {'measure': 'Contrast/Flush Volumes', 'timeFrame': 'Day 0', 'description': 'Contrast and flush volumes are presented'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Total Occlusion', 'Optimal Coherence Tomography', 'Lumivascular'], 'conditions': ['Total Atherosclerotic Occlusion of Femoral Artery']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.avinger.com', 'label': 'Avinger web site'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing totally occluded femoropopliteal arteries.', 'detailedDescription': 'The purpose of this clinical study is to evaluate the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing chronic total occlusions (CTOs) in femoropopliteal arteries. The Ocelot Catheter is a minimally invasive percutaneous device that is designed to traverse arterial occlusions through the use of spiral wedges contained in the distal tip of the device. The device is also equipped with an OCT (optical coherence tomography) imaging fiber that provides directional orientation and an intravascular view of the vessel wall and target lesion. The Ocelot Catheter is used in conjunction with standard endovascular devices and as an adjunct to fluoroscopic guidance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is willing and able to provide informed consent\n* Patient is willing and able to comply with the study protocol\n* Patient is \\> 18 years old\n* Patient has peripheral arterial disease requiring revascularization as evidenced by CTA, MRA or angiography\n* Patient has an occluded femoropopliteal artery that is 99-100% stenosed and is ≥ 1 cm and ≤ 30 cm in length by visual estimate\n* Target vessel is ≥ 3.0 mm in diameter\n* Patient has Rutherford Classification of 2-5\n* Lesion is recalcitrant to guidewire crossing\n\nExclusion Criteria:\n\n* Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated\n* Patient has a known sensitivity or allergy to aspirin, heparin or anti-platelet medications\n* Patient is pregnant or lactating\n* Patient has a co-existing disease or medical condition contraindicating percutaneous intervention\n* Target vessel is severely calcified as evidenced by angiography\n* Target lesion is in a bypass graft\n* Target lesion is in a stent (i.e., in-stent restenosis)\n* Patient has had a procedure on the target limb within 7 days\n* Patient has had a procedure on the target limb within the past 30 days and is unstable\n* Patient has a planned surgical or interventional procedure within 30 days after the study procedure\n* Patient is simultaneously participating in an investigational device study for treatment of peripheral vascular disease\n* Patient has a planned amputation of the target limb\n* Patient has a history of bleeding diathesis, coagulopathy or will refuse blood transfusion in cases of emergency'}, 'identificationModule': {'nctId': 'NCT01537302', 'acronym': 'CONNECTII', 'briefTitle': 'Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avinger, Inc.'}, 'officialTitle': 'A Non-randomized Study of the Avinger Ocelot System Used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries', 'orgStudyIdInfo': {'id': 'AVI OCT 10005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ocelot System', 'description': 'CTO crossing in femoropopliteal arteries using the Ocelot System', 'interventionNames': ['Device: CTO crossing in femoropopliteal arteries CONNECT II']}], 'interventions': [{'name': 'CTO crossing in femoropopliteal arteries CONNECT II', 'type': 'DEVICE', 'otherNames': ['Chronic TOtal OcclusioN CrossiNg with thE OCelot SysTem II', 'CONNECT II'], 'description': 'CTO crossing in femoropopliteal arteries using the Ocelot System', 'armGroupLabels': ['Ocelot System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Heart Hospital', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '95619', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Memorial', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '60007', 'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cardiovascular Associates - Alexian Brothers Medical Center', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'zip': '46802', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': "St. Joseph's Hospital", 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'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 Hospital and Medical Center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'St. Dominic Hospital', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'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': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Jobst Vascular Center', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '19010', 'city': 'Bryn Mawr', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bryn Mawr Hospital', 'geoPoint': {'lat': 40.30396, 'lon': -80.08672}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Heart', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'El Paso Cardiology Associates', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'The Heart Hospital Baylor Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Leipzig Hospital', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '48145', 'city': 'Münster', 'country': 'Germany', 'facility': 'Muenster Hospital', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '30035', 'city': 'Mirano', 'country': 'Italy', 'facility': 'Mirano Hospital', 'geoPoint': {'lat': 45.49458, 'lon': 12.10775}}], 'overallOfficials': [{'name': 'Matthew Selmon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Austin Heart Hospital'}, {'name': 'Arne Schwindt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Muenster Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avinger, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}