Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-03-01 @ 6:10 AM
Study NCT ID:
NCT01436435
Status:
COMPLETED
Last Update Posted:
2016-10-19
First Post:
2011-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Jetstream (JET) Post-market Registry
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': 'deeann.tinjum@bsci.com', 'phone': '763-494-1927', 'title': 'DeeAnn Tinjum, Clinical Trial Manager', 'organization': 'Boston Scientific'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Index procedure through 12 month follow up', 'eventGroups': [{'id': 'EG000', 'title': 'Jetstream Atherectomy System', 'description': 'Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.\n\nJetstream Atherectomy System: Atherectomy', 'otherNumAtRisk': 241, 'otherNumAffected': 38, 'seriousNumAtRisk': 241, 'seriousNumAffected': 42}], 'otherEvents': [{'term': 'Peripheral Artery Disease', 'notes': 'Includes target and non-target study limbs/lesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 49, 'numAffected': 38}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Target Vessel Revascularization/ Target Lesion Revascularization', 'notes': 'Device and/or Procedure Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 38, 'numAffected': 38}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Distal Embolization Requiring a Separate Intervention', 'notes': 'Device Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Amputation', 'notes': 'Device Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Binary Restenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jetstream Atherectomy System', 'description': 'Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.\n\nJetstream Atherectomy System: Atherectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of patients with binary restenosis at 12 months as defined by duplex ultrasound derived systolic velocity ratio \\>2.5. Binary restenosis will be measured by duplex ultrasound technology.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 184 participants were not evaluable.'}, {'type': 'SECONDARY', 'title': 'Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jetstream Atherectomy System', 'description': 'Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.\n\nJetstream Atherectomy System: Atherectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Index Procedure', 'description': 'Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint'}, {'type': 'SECONDARY', 'title': 'Ankle-Brachial Index (ABI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jetstream Atherectomy System', 'description': 'Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.\n\nJetstream Atherectomy System: Atherectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.'}, {'type': 'SECONDARY', 'title': 'Ankle-Brachial Index (ABI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jetstream Atherectomy System', 'description': 'Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.\n\nJetstream Atherectomy System: Atherectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 51 participants were not evaluable.'}, {'type': 'SECONDARY', 'title': 'Ankle-Brachial Index (ABI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jetstream Atherectomy System', 'description': 'Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.\n\nJetstream Atherectomy System: Atherectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '58.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 64 participants were not evaluable.'}, {'type': 'SECONDARY', 'title': 'Major Adverse Events (MAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jetstream Atherectomy System', 'description': 'Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.\n\nJetstream Atherectomy System: Atherectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Number of Major Adverse Events as defined by amputation, death, Target Lesion Revascularization, Target Vessel Revascularization, Myocardial Infarction or angiographic distal embolization that requires a separate intervention or hospitalization through 30 days', 'unitOfMeasure': 'Major Adverse Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Jetstream Atherectomy System', 'description': 'Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.\n\nJetstream Atherectomy System: Atherectomy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '241'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Jetstream Atherectomy System', 'description': 'Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.\n\nJetstream Atherectomy System: Atherectomy'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.1', 'spread': '9.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '159', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '241', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 241}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-03', 'studyFirstSubmitDate': '2011-09-02', 'resultsFirstSubmitDate': '2016-07-16', 'studyFirstSubmitQcDate': '2011-09-16', 'lastUpdatePostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-16', 'studyFirstPostDateStruct': {'date': '2011-09-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Binary Restenosis', 'timeFrame': '12 months', 'description': 'Percentage of patients with binary restenosis at 12 months as defined by duplex ultrasound derived systolic velocity ratio \\>2.5. Binary restenosis will be measured by duplex ultrasound technology.'}], 'secondaryOutcomes': [{'measure': 'Procedural Success', 'timeFrame': 'Index Procedure', 'description': 'Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy'}, {'measure': 'Ankle-Brachial Index (ABI)', 'timeFrame': '30 days', 'description': 'Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.'}, {'measure': 'Ankle-Brachial Index (ABI)', 'timeFrame': '6 months', 'description': 'Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.'}, {'measure': 'Ankle-Brachial Index (ABI)', 'timeFrame': '12 months', 'description': 'Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.'}, {'measure': 'Major Adverse Events (MAE)', 'timeFrame': '30 days', 'description': 'Number of Major Adverse Events as defined by amputation, death, Target Lesion Revascularization, Target Vessel Revascularization, Myocardial Infarction or angiographic distal embolization that requires a separate intervention or hospitalization through 30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PAD', 'peripheral artery disease', 'atherectomy'], 'conditions': ['Peripheral Arterial Diseases']}, 'descriptionModule': {'briefSummary': 'The scope of the JET registry to observe long term treatment effects of Jetstream Navitus on various lesions types/morphologies.', 'detailedDescription': '* To observe the treatment effects of the Jetstream NAVITUS System in long, occluded, diffuse, thrombotic or calcified lesions in peripheral arterial disease of the common femoral, superficial femoral, or popliteal arteries.\n* To assess and quantify vessel patency 1 year post atherectomy treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is ≥ 18 years of age.\n* The target de novo or restenotic Percutaneous Transluminal Angioplasty (PTA) lesion(s) is/are located in the common femoral, superficial femoral or popliteal arteries.\n* The reference vessel lumen (proximal to target lesion) is ≥ 4.0mm.\n* Evidence of ≥ 70% stenosis or occlusion confirmed by angiography.\n* Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course before the patient is considered as entered into the study.\n* Patient is an acceptable candidate for percutaneous intervention using the Jetstream NAVITUS System in accordance with its labeled indications and instructions for use.\n* Lesion length ≥ 4cm.\n* Patient has a Rutherford category score of 1-3.\n* Patient has signed approved informed consent.\n* Patient is willing to comply with the follow-up evaluations at specified times.\n\nExclusion Criteria:\n\n* Patient has an uncontrollable allergy to nitinol, stainless steel or other stent materials or to contrast agent.\n* Patient is unable to take appropriate anti-platelet therapy.\n* Patient has no patent distal runoff vessels.\n* Patient has critical limb ischemia (i.e., Rutherford class 4-6)\n* Limited vascular access that precludes safe advancement of the Jetstream NAVITUS System to the target lesion(s).\n* Interventional treatment is intended for in-stent restenosis.\n* Patient has target vessel with moderate or severe angulation (e.g., \\>30 degrees) or tortuosity at the treatment segment.\n* Patient has a history of coagulopathy or hypercoagulable bleeding disorder.\n* Patient is receiving hemodialysis or has significantly impaired renal function (creatinine is \\> 2.5 mg/dl) at the time of treatment.\n* Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months.\n* Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.\n* Patient has had surgical or endovascular procedure in the same vascular territory within 30 days prior to the index procedure.\n* Patient has any planned surgical intervention or endovascular procedure within 30 days after the index procedure.\n* Use of another debulking device during the index procedure prior to the Jetstream NAVITUS System will exclude the patient.'}, 'identificationModule': {'nctId': 'NCT01436435', 'acronym': 'JET', 'briefTitle': 'The Jetstream (JET) Post-market Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Jetstream NAVITUS™ System Endovascular Therapy Post-market Registry (JET)', 'orgStudyIdInfo': {'id': 'D1465'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Jetstream Atherectomy System', 'description': 'Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.', 'interventionNames': ['Device: Jetstream Atherectomy System']}], 'interventions': [{'name': 'Jetstream Atherectomy System', 'type': 'DEVICE', 'description': 'Atherectomy', 'armGroupLabels': ['Jetstream Atherectomy System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Nelson Bernardo MD', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33141', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Robert Beasley, MD', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '52803', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Nicolas Shammas, MD', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '02135', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lawrence Garcia, MD', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '39440', 'city': 'Laurel', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Vinay Kumar', 'geoPoint': {'lat': 31.69405, 'lon': -89.13061}}, {'zip': '08822', 'city': 'Flemington', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Andrey Espinoza, MD', 'geoPoint': {'lat': 40.51233, 'lon': -74.85933}}, {'zip': '11734', 'city': 'Huntington', 'state': 'New York', 'country': 'United States', 'facility': 'Sotir Polena, MD', 'geoPoint': {'lat': 40.86815, 'lon': -73.42568}}, {'zip': '17110', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rajesh Dave, MD', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '19611', 'city': 'West Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Ali Amin, MD', 'geoPoint': {'lat': 40.3337, 'lon': -75.94743}}, {'zip': '29204', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Lee Butterfield, MD', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Chris Metzger, MD', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}], 'overallOfficials': [{'name': 'William Gray, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}