Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-27 @ 6:39 AM
Study NCT ID:
NCT02812966
Status:
TERMINATED
Last Update Posted:
2024-10-08
First Post:
2016-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lutonix or Inpact for tHE tReatment Of fEmeropopliteal Stenosis - Drug Coated Balloon
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'laura.wrona@aah.org', 'phone': '708-860-7792', 'title': 'Director, Clinical Trials Research Cardiovascular and Multiple Specialties', 'organization': 'Advocate Aurora Research Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'In this study we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of enrollment/randomization through study exit, up to 12 months.', 'description': 'Participants asked when they came in if there was an adverse event', 'eventGroups': [{'id': 'EG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter\n\nLutonix: Drug Coated Balloons', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'IN.PACT Drug Coated Balloon', 'description': 'IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter\n\nIN.PACT: Drug Coated Balloons', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'subdural hematoma', 'notes': 'Subject presented with neck pain, left arm weakness, and was diagnosed subdural hematoma attributed to a fall. Subject was hospitalized and underwent multiple surgeries. Subject developed seizures, pneumonia, and required mechanical ventilation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Patency (Peak Systolic Velocity Ratio<=2.4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter\n\nLutonix: Drug Coated Balloons'}, {'id': 'OG001', 'title': 'IN.PACT Drug Coated Balloon', 'description': 'IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter\n\nIN.PACT: Drug Coated Balloons'}], 'timeFrame': '12 months', 'description': 'Peak systolic velocity ratio \\<=2.4 (by duplex ultrasound scanning) with no target lesion revascularization or target lesion bypass', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected.\n\nInsufficient number of participants enrolled to perform data analysis prior to study closure. No data displayed because outcome measure had zero total participants analyzed.'}, {'type': 'SECONDARY', 'title': 'Target Lesion Revascularization Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter\n\nLutonix: Drug Coated Balloons'}, {'id': 'OG001', 'title': 'IN.PACT Drug Coated Balloon', 'description': 'IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter\n\nIN.PACT: Drug Coated Balloons'}], 'timeFrame': '12 months', 'description': 'To examine, describe and compare/contrast within and between Drug Coated Balloon groups.\n\n1. Target lesion revascularization rate\n2. Safety event rate\n3. Healthcare utilization costs', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected.\n\nInsufficient number of participants enrolled to perform data analysis prior to study closure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter\n\nLutonix: Drug Coated Balloons'}, {'id': 'FG001', 'title': 'IN.PACT Drug Coated Balloon', 'description': 'IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter\n\nIN.PACT: Drug Coated Balloons'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lutonix Drug Coated Balloon', 'description': 'Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter\n\nLutonix: Drug Coated Balloons'}, {'id': 'BG001', 'title': 'IN.PACT Drug Coated Balloon', 'description': 'IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter\n\nIN.PACT: Drug Coated Balloons'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'No data received on 4 subjects in the Lutonix Drug Coated Balloon arm. No data received on 4 subjects in the IN.PACT Drug Coated Balloon arm.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-01', 'size': 505367, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-27T12:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'whyStopped': 'new FDA information regarding drug-coated balloons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2016-06-21', 'resultsFirstSubmitDate': '2023-07-12', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-29', 'studyFirstPostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Patency (Peak Systolic Velocity Ratio<=2.4)', 'timeFrame': '12 months', 'description': 'Peak systolic velocity ratio \\<=2.4 (by duplex ultrasound scanning) with no target lesion revascularization or target lesion bypass'}], 'secondaryOutcomes': [{'measure': 'Target Lesion Revascularization Rate', 'timeFrame': '12 months', 'description': 'To examine, describe and compare/contrast within and between Drug Coated Balloon groups.\n\n1. Target lesion revascularization rate\n2. Safety event rate\n3. Healthcare utilization costs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['peripheral arterial disease', 'drug coated balloon'], 'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'Investigators hypothesize in patients presenting with significant peripheral arterial disease with clinical indications for treatment with angioplasty, there will be a difference in 12 month patency between the subjects with Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter and IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter.', 'detailedDescription': 'Investigators hypothesize in patients presenting with significant peripheral arterial disease with clinical indications for treatment with angioplasty, there will be a difference in the 12 month patency (defined as peak systolic velocity ratio \\<=2.4 at 12 month follow-up visit with no target lesion revascularization or target lesion bypass) between the subjects with Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter and IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter. Investigators will also assess and compare target lesion revascularization rates, safety profiles, adverse events, healthcare costs, and healthcare utilization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient is willing and able to provide informed consent, willing and agrees to comply with regular follow up visits, testing, medication regimen compliance any another treatments deemed necessary for treatment of vascular disease.\n2. Male or non-pregnant female\n3. Age greater \\>=18 years of age\n4. Patients with moderate to severe claudication or ischemic rest pain as defined by Rutherford 2-4 class symptoms\n5. \\>=1 tibial run-off vessel at baseline\n6. Angiographic criteria\n\n * \\>=70% stenosis (via visual angiographic estimate in the superficial femoral artery and/or popliteal arteries as appropriate)\n * 4-7 mm vessel diameter\n * \\<=15 cm for planned treatment segment length.\n * Planned treatment segments are to no further proximal than 1 cm from the bifurcation of the common femoral artery and no further distal than the 1 cm above the tibioperoneal trunk.\n * Lesions treated within the target vessel are either De Novo lesions or not previously stented restenotic segments of the superficial femoral artery and/or popliteal artery that are greater than 90 days from prior angioplasty procedure\n * If the target vessel was previously stented the treated lesion must be at least 3 cm from the previously placed stent\n * Lesion must be able to be treated with either drug coated balloon device based on the sizes specifications of both devices\n * Successful, uncomplicated crossing must be possible within the treated lesion either with or without a crossing device\n * Inflow artery must be free from significant occlusive disease (\\< 50%) as confirmed by visual estimation by angiography otherwise the inflow artery must be treated beforehand.\n * At least 1 patent vessel outflow from the target vessel treated must be present by angiography\n\nExclusion Criteria:\n\n1. Unable to meet clinical criteria to have peripheral angioplasty and follow-up treatment (lab values and pregnancy test)\n2. Contra-indicated to either drug coated balloon\n3. \\< 18 years of age at time of consent and/or index procedure\n4. Pregnant or breastfeeding\n5. In-stent restenosis within the target lesion\n6. Previously stented target lesion/vessel.\n7. Target lesion/vessel previously treated with drug-coated balloon \\<12 months prior to randomization/enrollment.\n8. Perforated vessel as evidenced by extravasation of contrast media prior to consent or enrollment.\n9. Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention \\<=30 days of consent or randomization.\n10. Presence of aneurysm in the target vessel.\n11. Major amputation in the target limb.\n12. Subjects who have undergone prior surgery of the superficial femoral artery/proximal popliteal artery in the target limb to treat atherosclerotic disease.\n13. Use of atherectomy, laser or other debulking devices in the target limb superficial femoral artery/proximal popliteal artery during the index procedure.\n14. Acute ischemia and/or acute thrombosis of the superficial femoral artery/proximal popliteal artery prior to consent or randomization.\n15. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the local investigator, cannot be adequately pre-medicated.\n16. Known hypersensitivity/allergy to the investigational stent system or protocol related therapies.\n17. On dialysis or on an immunosuppressant therapy.\n18. Concomitant renal failure (including serum creatinine \\>2.0 mg/dL.)\n19. Occurrence of myocardial infarction or cerebrovascular accident \\<=6 months prior to consent.\n20. Platelet count \\<80,000 mm3 or \\>600,000 mm3 or history of bleeding diathesis.\n21. Unstable angina pectoris at the time of consent or randomization.\n22. Septicemia at the time of consent or randomization.\n23. Moderate to severely calcified lesions.'}, 'identificationModule': {'nctId': 'NCT02812966', 'acronym': 'HEROES-DCB', 'briefTitle': 'Lutonix or Inpact for tHE tReatment Of fEmeropopliteal Stenosis - Drug Coated Balloon', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Lutonix or Inpact for tHE tReatment Of fEmeropopliteal Stenosis - Drug Coated Balloon', 'orgStudyIdInfo': {'id': 'C5000163'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lutonix Drug Coated Balloon', 'description': 'Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter', 'interventionNames': ['Device: Lutonix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IN.PACT Drug Coated Balloon', 'description': 'IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter', 'interventionNames': ['Device: IN.PACT']}], 'interventions': [{'name': 'Lutonix', 'type': 'DEVICE', 'description': 'Drug Coated Balloons', 'armGroupLabels': ['Lutonix Drug Coated Balloon']}, {'name': 'IN.PACT', 'type': 'DEVICE', 'description': 'Drug Coated Balloons', 'armGroupLabels': ['IN.PACT Drug Coated Balloon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Illinois Masonic Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60515', 'city': 'Downers Grove', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Good Samaritan Hospital', 'geoPoint': {'lat': 41.80892, 'lon': -88.01117}}, {'zip': '60429', 'city': 'Hazel Crest', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate South Suburban Hospital', 'geoPoint': {'lat': 41.5717, 'lon': -87.69449}}, {'zip': '60540', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Hospital', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}, {'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Christ Medical Center', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '62701', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Prairie Education and Research Collaborative', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}], 'overallOfficials': [{'name': 'Jaafer Golzar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}