Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-02 @ 4:02 PM
Study NCT ID:
NCT02961894
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2016-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017073', 'term': 'Atherectomy'}, {'id': 'D017225', 'term': 'Atherectomy, Coronary'}], 'ancestors': [{'id': 'D017130', 'term': 'Angioplasty'}, {'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009204', 'term': 'Myocardial Revascularization'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cvalentis@rexmedical.com', 'phone': '610-629-6051', 'title': 'Colin Valentis', 'organization': 'Rex Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.', 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 78, 'seriousNumAtRisk': 121, 'deathsNumAffected': 3, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Blood and lymphatic system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocrine disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatobiliary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Product issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reproductive system and breast disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical and medical procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 37}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Clinically Driven TLR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major target limb amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Perforation of target vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Distal embolization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'All-cause mortality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety Endpoint: Number of Participants With Freedom From Major Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30-Day', 'description': 'Freedom from Major Adverse Events is defined as the composite of all-cause mortality, clinically-driven target lesion revascularization (TLR), major target limb amputation, major target vessel perforation requiring surgical or endovascular repair, and clinically-significant distal embolization in the target limb; as adjudicated by an independent Clinical Events Committee The primary safety endpoint is freedom from 30-day Major Adverse Events (MAE), defined as the composite of all-cause mortality, clinically-driven target lesion revascularization (TLR), major target limb amputation, major target vessel perforation requiring surgical or endovascular repair and clinically-significant distal embolization in the target limb; as adjudicated by the independent Clinical Events Committee (CEC).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Effectiveness Endpoint: Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.'}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '1-Day', 'description': 'Technical success is defined by ≤50% diameter stenosis after atherectomy with the Revolution™ Peripheral Atherectomy System and prior to adjunctive therapy, as measured by the independent core laboratory on the post-atherectomy contrast angiogram. Effectiveness will be assessed for investigator-identified target lesions and will be calculated as a binary variable as the percentage of target lesions with technical success.', 'unitOfMeasure': 'Lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'SECONDARY', 'title': 'Target Lesion Revascularization (TLR) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Target Lesion Revascularization (TLR) rate through 30 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in % Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'spread': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-Day', 'description': 'Change in % stenosis after treatment with Revolution™ Peripheral Atherectomy System, determined after atherectomy and prior to other adjunctive therapies, as measured by the angiographic core laboratory.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'SECONDARY', 'title': 'Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.'}], 'classes': [{'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '1-Day', 'description': 'Procedural success as defined by target lesion residual stenosis of \\<30% at the conclusion of the index procedure, after atherectomy and any adjunctive endovascular treatment, as measured by the angiographic core laboratory.', 'unitOfMeasure': 'Lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions', 'populationDescription': '132 total lesions in the Per Protocol dataset. Images missing for 2 lesions; calibration missing for 3 lesions therefore only 127 post procedure angiograms available.'}, {'type': 'SECONDARY', 'title': 'Assessment of the Combined Components of the Primary Safety Endpoint, Freedom From MAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Assessment of the total combined components of the primary safety endpoint (Freedom from MAE); including all-cause mortality, major target limb amputation, clinically significant distal embolization, major target vessel perforation requiring surgical or endovascular repair, and clinically-driven TLR, measured through 6 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Freedom From Target Lesion Revascularization (TLR) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Freedom from Target Lesion Revascularization (TLR) rate through 6 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Freedom From Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.'}], 'classes': [{'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Freedom from Myocardial infarction through 30 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Freedom From Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.'}], 'classes': [{'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Freedom from Myocardial infarction through 6 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Freedom From Target Vessel Revascularization (TVR) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.'}], 'classes': [{'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Freedom from incidence of target vessel revascularization (TVR) through 30 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Freedom From Target Vessel Revascularization (TVR) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.'}], 'classes': [{'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Freedom from incidence of target vessel revascularization (TVR) through 6 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Freedom From Angiographic Procedural Distal Embolization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.'}], 'classes': [{'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-Day', 'description': 'Freedom from angiographic procedural distal embolization (symptomatic) in the target limb as confirmed angiographically by the core laboratory.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Primary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.'}], 'classes': [{'title': '30 Days', 'categories': [{'measurements': [{'value': '99.1', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '81.6', 'spread': '4.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 Days, 6 months', 'description': 'Primary patency of the target lesion at 30 days and 6 months, determined by duplex ultrasound or angiography.', 'unitOfMeasure': 'Percentage of primary patency', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions', 'populationDescription': 'Among the 132 lesions in the Per Protocol dataset, four were excluded from the patency analyses due to missing post-atherectomy angiograms, leaving 128 lesions in the analysis.'}, {'type': 'SECONDARY', 'title': 'Assisted Primary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}, {'units': 'Number of Per protocol lesions', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.'}], 'classes': [{'title': '30 Days', 'categories': [{'measurements': [{'value': '99.1', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '87.7', 'spread': '3.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 Days, 6 months', 'description': 'Primary-assisted patency of the target lesion at 30 days and 6 months, determined by duplex ultrasound or angiography.', 'unitOfMeasure': 'Percentage of assisted primary patency', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Per protocol lesions', 'denomUnitsSelected': 'Number of Per protocol lesions', 'populationDescription': 'Among the 132 lesions in the Per Protocol dataset, four were excluded from the patency analyses due to missing post-atherectomy angiograms, leaving 128 lesions in the analysis.'}, {'type': 'SECONDARY', 'title': 'Secondary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}, {'units': 'Number of Per protocol lesions', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.'}], 'classes': [{'title': '30 Days', 'categories': [{'measurements': [{'value': '99.1', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '91.6', 'spread': '2.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 Days, 6 months', 'description': 'Secondary patency of the target lesion at 30 days and 6 months, determined by duplex ultrasound or angiography.', 'unitOfMeasure': 'Percentage of secondary patency', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Per protocol lesions', 'denomUnitsSelected': 'Number of Per protocol lesions', 'populationDescription': 'Among the 132 lesions in the Per Protocol dataset, four were excluded from the patency analyses due to missing post-atherectomy angiograms, leaving 128 lesions in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.\n\nRevolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '72', 'spread': '9.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', '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': '121', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-01', 'size': 1996140, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-10-08T13:22', 'hasProtocol': True}, {'date': '2019-08-01', 'size': 564622, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-10-08T13:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-08', 'studyFirstSubmitDate': '2016-11-07', 'resultsFirstSubmitDate': '2020-08-10', 'studyFirstSubmitQcDate': '2016-11-08', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-08', 'studyFirstPostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Endpoint: Number of Participants With Freedom From Major Adverse Events', 'timeFrame': '30-Day', 'description': 'Freedom from Major Adverse Events is defined as the composite of all-cause mortality, clinically-driven target lesion revascularization (TLR), major target limb amputation, major target vessel perforation requiring surgical or endovascular repair, and clinically-significant distal embolization in the target limb; as adjudicated by an independent Clinical Events Committee The primary safety endpoint is freedom from 30-day Major Adverse Events (MAE), defined as the composite of all-cause mortality, clinically-driven target lesion revascularization (TLR), major target limb amputation, major target vessel perforation requiring surgical or endovascular repair and clinically-significant distal embolization in the target limb; as adjudicated by the independent Clinical Events Committee (CEC).'}, {'measure': 'Effectiveness Endpoint: Technical Success', 'timeFrame': '1-Day', 'description': 'Technical success is defined by ≤50% diameter stenosis after atherectomy with the Revolution™ Peripheral Atherectomy System and prior to adjunctive therapy, as measured by the independent core laboratory on the post-atherectomy contrast angiogram. Effectiveness will be assessed for investigator-identified target lesions and will be calculated as a binary variable as the percentage of target lesions with technical success.'}], 'secondaryOutcomes': [{'measure': 'Target Lesion Revascularization (TLR) Rate', 'timeFrame': '30 Days', 'description': 'Target Lesion Revascularization (TLR) rate through 30 days.'}, {'measure': 'Change in % Stenosis', 'timeFrame': '1-Day', 'description': 'Change in % stenosis after treatment with Revolution™ Peripheral Atherectomy System, determined after atherectomy and prior to other adjunctive therapies, as measured by the angiographic core laboratory.'}, {'measure': 'Procedural Success', 'timeFrame': '1-Day', 'description': 'Procedural success as defined by target lesion residual stenosis of \\<30% at the conclusion of the index procedure, after atherectomy and any adjunctive endovascular treatment, as measured by the angiographic core laboratory.'}, {'measure': 'Assessment of the Combined Components of the Primary Safety Endpoint, Freedom From MAE', 'timeFrame': '6 months', 'description': 'Assessment of the total combined components of the primary safety endpoint (Freedom from MAE); including all-cause mortality, major target limb amputation, clinically significant distal embolization, major target vessel perforation requiring surgical or endovascular repair, and clinically-driven TLR, measured through 6 months.'}, {'measure': 'Freedom From Target Lesion Revascularization (TLR) Rate', 'timeFrame': '6 months', 'description': 'Freedom from Target Lesion Revascularization (TLR) rate through 6 months.'}, {'measure': 'Freedom From Myocardial Infarction', 'timeFrame': '30 Days', 'description': 'Freedom from Myocardial infarction through 30 days.'}, {'measure': 'Freedom From Myocardial Infarction', 'timeFrame': '6 months', 'description': 'Freedom from Myocardial infarction through 6 months.'}, {'measure': 'Freedom From Target Vessel Revascularization (TVR) Rate', 'timeFrame': '30 Days', 'description': 'Freedom from incidence of target vessel revascularization (TVR) through 30 days.'}, {'measure': 'Freedom From Target Vessel Revascularization (TVR) Rate', 'timeFrame': '6 months', 'description': 'Freedom from incidence of target vessel revascularization (TVR) through 6 months.'}, {'measure': 'Freedom From Angiographic Procedural Distal Embolization', 'timeFrame': '1-Day', 'description': 'Freedom from angiographic procedural distal embolization (symptomatic) in the target limb as confirmed angiographically by the core laboratory.'}, {'measure': 'Primary Patency', 'timeFrame': '30 Days, 6 months', 'description': 'Primary patency of the target lesion at 30 days and 6 months, determined by duplex ultrasound or angiography.'}, {'measure': 'Assisted Primary Patency', 'timeFrame': '30 Days, 6 months', 'description': 'Primary-assisted patency of the target lesion at 30 days and 6 months, determined by duplex ultrasound or angiography.'}, {'measure': 'Secondary Patency', 'timeFrame': '30 Days, 6 months', 'description': 'Secondary patency of the target lesion at 30 days and 6 months, determined by duplex ultrasound or angiography.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Atherectomy', 'Atherosclerosis'], 'conditions': ['Peripheral Artery Disease']}, 'referencesModule': {'references': [{'pmid': '34624496', 'type': 'DERIVED', 'citation': 'Carr J, Bowman J, Watts M, Ouriel K, Dave R. United States Investigational Device Exemption study of the Revolution Peripheral Atherectomy System. J Vasc Surg. 2022 Mar;75(3):976-986.e4. doi: 10.1016/j.jvs.2021.08.107. Epub 2021 Oct 5.'}], 'seeAlsoLinks': [{'url': 'http://www.rexmedical.com/', 'label': 'RexMedical.com'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in the treatment of infrainguinal lower extremity peripheral arterial occlusive disease.\n\nThis Atherectomy system will be used on eligible patients with stenosis of at least 70% diameter reduction to evaluate the change in stenosis after the procedure (effectiveness) and the presence of any major adverse events (safety) for up to 30 days after the procedure.', 'detailedDescription': 'This study intends to enroll up to 121 subjects at up to 18 investigational sites in the United States. This is a single-arm study of the Revolution™ Peripheral Atherectomy System in subjects with peripheral arterial disease (PAD).\n\nThe primary safety endpoint is freedom from 30-day Major Adverse Events (MAE), defined as the composite of all-cause mortality, clinically-driven target lesion revascularization (TLR), major target limb amputation, major target vessel perforation requiring surgical or endovascular repair and clinically-significant distal embolization in the target limb; as adjudicated by the independent Clinical Events Committee (CEC).\n\nThe primary effectiveness endpoint is technical success, defined by ≤50% diameter stenosis after atherectomy with the Revolution™ Peripheral Atherectomy System and prior to adjunctive therapy, as measured by the independent core laboratory on the post-atherectomy contrast angiogram. Effectiveness will be assessed for investigator-identified target lesions and will be calculated as a binary variable as the proportion of target lesions with technical success.\n\nThe following will be assessed as secondary endpoints of the study:\n\n1. Change in % stenosis after treatment with Revolution™ Peripheral Atherectomy System, determined after atherectomy and prior to other adjunctive therapies, as measured by the angiographic core laboratory.\n2. Procedural success as defined by target lesion residual stenosis of \\<30% at the conclusion of the index procedure, after atherectomy and any adjunctive endovascular treatment, as measured by the angiographic core laboratory.\n3. Assessment of the individual components of the primary safety endpoint (MAE); including all-cause mortality, major target limb amputation, clinically significant distal embolization, major target vessel perforation requiring surgical or endovascular repair, and clinically-driven TLR, measured through 30 days and at 6 months.\n4. Minor unplanned target limb amputation rate through 30 days and 6 months;\n5. Myocardial infarction through 30 days and 6 months;\n6. Incidence of target vessel revascularization (TVR) through 30 days and 6 months;\n7. Frequency of angiographic procedural distal embolization (symptomatic) in the target limb as confirmed angiographically by the core laboratory;\n8. Primary patency of the target lesion at 30 days and 6 months, determined by duplex ultrasound or angiography;\n9. Primary-assisted patency of the target lesion at 30 days and 6 months, determined by duplex ultrasound or angiography;\n10. Secondary patency of the target lesion at 30 days and 6 months, determined by duplex ultrasound or angiography.\n\nSubjects with symptomatic PAD eligible for treatment with the Revolution™ Peripheral Atherectomy System with atherosclerotic lesions of the superficial femoral, popliteal and tibial arteries will be eligible for inclusion in the study.\n\nA performance goal of 80% for safety and 76% for effectiveness has been established from prior studies. Enrollment of 121 subjects will provide 90% power, based upon a one-sided 97.5% exact binomial test, an anticipated 30-day MAE rate of 9%, acute technical success of 86%, and a 30-day attrition rate of approximately 10%.\n\nThe regulatory submission will be based on an approximate sample size of 121 subjects. Assuming a lesion-to-subject ratio of 1.5, approximately 165 target lesions will be evaluable for the primary effectiveness endpoint. Subset analyses will be performed for device effectiveness for superficial femoral/popliteal and tibial artery target lesions.\n\nPre-Enrollment procedures include testing, reviewing Medical history, physical examination with vital signs and directed peripheral vascular examination, laboratory assessment, ankle-brachial or toe-brachial index, and patient-reported outcome measures. The diagnostic angiogram at time of the planned index procedure is performed prior to the point of enrollment in the study; eligibility is, in part, based upon the anatomic findings of the angiogram.\n\nSubjects will have required follow-up evaluations at the following time points:\n\n1. Discharge;\n2. 1 month post index procedure;\n3. 6 months post index procedure;\n\nFollow-Up Data Collection:\n\n1. Adverse Events at the index procedure, hospital discharge, and through 6 months;\n2. Rutherford Classification at 1 and 6 months;\n3. Ankle-brachial or toe-brachial index at 1 and 6 months;\n4. Duplex ultrasound of the target vessel at 1 and 6 months.\n\nAn independent Clinical Events Committee (CEC) will review all primary safety endpoint events, unanticipated adverse device effects, and other important safety occurrences as specified in the CEC Charter. Additionally, an independent Data Safety Monitoring Board (DSMB) will review safety data from the study at predetermined time points and as deemed necessary by the Sponsor or the DSMB Chair. The DSMB will make recommendations on protocol modifications and continuation of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Willing and able to provide informed consent.\n3. Ability to take at least one form of anti-platelet therapy.\n4. Rutherford categories 2 to 5 in the target limb.\n5. Lesions to be treated with the study device must be located in the same limb.\n6. Target lesion(s) located within the superficial femoral, popliteal or tibial arteries.\n7. Target lesion(s) with stenosis ≥70% diameter reduction as measured by site-reported angiography.\n8. Target lesion length(s) ≤150 mm.\n9. Target lesions(s) with reference vessel diameter (proximal and distal to target lesion) ≥2.0 mm and ≤4.0 mm.\n\nExclusion Criteria:\n\n1. Subjects in whom amputation above the ankle is necessary, irrespective of the success of revascularization.\n2. In-stent restenosis within the target lesion.\n3. Flow-limiting dissection, Type C or greater.\n4. Target lesions within an autogenous or prosthetic bypass graft.\n5. History of an endovascular procedure or open vascular reconstruction in the index limb within the last 30 days, including thrombolytic therapy.\n6. Any open vascular surgical procedure planned in the target limb or endovascular procedures planned in the target vessel within 30 days after the index procedure.\n7. Kidney disease of sufficient severity, in the Investigator's opinion, to contraindicate lower extremity angiography using standard or alternate contrast agents as per the local Standard of Care.\n8. Pregnancy or breast feeding. A woman of child-bearing potential must have a negative pregnancy test within one week of index procedure.\n9. Myocardial infarction or stroke within 2 months of enrollment.\n10. Contraindication to antiplatelet, anticoagulant, or thrombolytic therapy.\n11. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count \\< 125,000/μL, known coagulopathy, or INR \\> 1.5.\n12. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pretreated in the opinion of the investigator.\n13. History of heparin-induced thrombocytopenia.\n14. Psychiatric disorder which, according to the investigator, has potential to interfere with provision of informed consent, completion of tests, therapy, or follow-up.\n15. Clinical/angiographic evidence of distal embolization or acute thrombus.\n16. Significant stenosis (\\>50% diameter reduction) or occlusion of inflow vessels that was not successfully treated (\\<50% residual stenosis without flow limiting dissection) before the study intervention."}, 'identificationModule': {'nctId': 'NCT02961894', 'acronym': 'REVEAL', 'briefTitle': 'Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rex Medical'}, 'officialTitle': 'Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization', 'orgStudyIdInfo': {'id': 'REX-US-2017-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Revolution Treatment Arm', 'description': 'This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.', 'interventionNames': ['Device: Revolution™ Peripheral Atherectomy System']}], 'interventions': [{'name': 'Revolution™ Peripheral Atherectomy System', 'type': 'DEVICE', 'otherNames': ['Revolution Peripheral Atherectomy System', 'Percutaneous Transluminal Atherectomy', 'Rotational Atherectomy'], 'description': 'The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.', 'armGroupLabels': ['Revolution Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06820', 'city': 'Darien', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Vascular Breakthroughs', 'geoPoint': {'lat': 41.07871, 'lon': -73.46929}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'First Coast Cardiovascular Institute', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33319', 'city': 'Lauderdale Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Precision Clinical Research', 'geoPoint': {'lat': 26.16647, 'lon': -80.20838}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Coastal Vascular and Interventional', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "St. Joseph's Hospital", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46321', 'city': 'Munster', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Health', 'geoPoint': {'lat': 41.56448, 'lon': -87.51254}}, {'zip': '48126', 'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Outpatient Vascular Institute', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}, {'zip': '08330', 'city': 'Mays Landing', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Vascular Access Center', 'geoPoint': {'lat': 39.45234, 'lon': -74.72766}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'North Carolina Heart and Vascular', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '16701', 'city': 'Bradford', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny Vein & Vascular', 'geoPoint': {'lat': 41.9559, 'lon': -78.64392}}, {'zip': '17011', 'city': 'Camp Hill', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Capital Area Research, LLC', 'geoPoint': {'lat': 40.23981, 'lon': -76.91997}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania Vascular Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Anderson Heart', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '75208', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'DFW Vascular Group', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77339', 'city': 'Kingwood', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Heart and Vascular', 'geoPoint': {'lat': 30.05691, 'lon': -95.18349}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Cardiovascular Associates of East Texas', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}], 'overallOfficials': [{'name': 'Jeffrey G Carr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular Associates of East Texas'}, {'name': 'Kenneth Ouriel, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Syntactx'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rex Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Syntactx', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}