Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-02 @ 4:08 AM
Study NCT ID:
NCT02514460
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2015-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Stent Versus Direct Atherectomy to Treat Lower Limb Ischemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015607', 'term': 'Stents'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-11', 'studyFirstSubmitDate': '2015-07-31', 'studyFirstSubmitQcDate': '2015-07-31', 'lastUpdatePostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '12-month Primary Patency Rate', 'timeFrame': '12 months', 'description': 'Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis \\>50% with a peak systolic velocity ratio \\>2.4 as measured by Duplex ultrasound.'}, {'measure': '12-month Limb Salvage Rate', 'timeFrame': '12 months', 'description': 'Limb Salvage is defined as the freedom from secondary major amputation'}], 'secondaryOutcomes': [{'measure': 'Index Limb Ischemia at 6-month Follow up', 'timeFrame': '6 months', 'description': 'Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.'}, {'measure': 'Index Limb Ischemia at 12-month Follow up', 'timeFrame': '12 months', 'description': 'Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.'}, {'measure': 'Major Adverse Events at 12-month Post Procedure', 'timeFrame': '12 months', 'description': 'Major adverse events included death, index limb ischemia, index limb amputation, clinically driven target lesion revascularization , and significant embolic events, which were defined as causing end-organ damage.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stents', 'atherectomy', 'femoral artery', 'popliteal artery'], 'conditions': ['Atherosclerosis', 'Ischemia']}, 'referencesModule': {'references': [{'pmid': '23822938', 'type': 'BACKGROUND', 'citation': 'Yongquan G, Lianrui G, Lixing Q, Xuefeng L, Zhu T, Shijun C, Yingfeng W, Jianming G, Jian Z, Zhonggao W. Plaque excision in the management of lower-limb ischemia of atherosclerosis and in-stent restenosis with the SilverHawk atherectomy catheter. Int Angiol. 2013 Aug;32(4):362-7.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized study comparing stent and plaque excision systems in treatment of lower limb (superficial femoral or popliteal artery) ischemia.', 'detailedDescription': 'This is a randomized study comparing stent and plaque excision systems in treatment of diabetic lower limb (superficial femoral or popliteal artery) ischemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nProvides written informed consent Willing to comply with follow-up evaluations at specified times Has claudication or rest pain due to peripheral arterial disease Disease located within the femoropopliteal artery Patient has a de novo or restenotic lesion(s) with \\>50% stenosis documented angiographically and no prior stent in the target lesion.\n\nPatient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.\n\nExclusion Criteria:\n\nPreviously implanted stent(s) or stent graft(s) in target leg Life expectancy less than 12 months Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days. Receiving dialysis or immunosuppressant therapy. Recent stroke within past 90 days. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, Nitinol (nickel titanium), contrast agent, that cannot be medically managed.\n\nTissue loss due to ischemic disease (Rutherford/Becker category 5 or 6) Serum creatinine level \\>/= 2.5 mg/dl at time of screening visit Known or suspected active infection at the time of the procedure Bleeding diathesis Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.\n\nPatient is known to be pregnant, incarcerated, mentally incompetent, and/or alcohol or drug abuser.\n\nPatient is currently participating in any other investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or future participation in such studies prior to the completion of this study.'}, 'identificationModule': {'nctId': 'NCT02514460', 'briefTitle': 'Clinical Study of Stent Versus Direct Atherectomy to Treat Lower Limb Ischemia', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'orgStudyIdInfo': {'id': 'Z141107002514063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention: Stents', 'description': 'Stents group', 'interventionNames': ['Device: Stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention: Atherectomy', 'description': 'Direct Atherectomy group', 'interventionNames': ['Device: plaque excision system']}], 'interventions': [{'name': 'plaque excision system', 'type': 'DEVICE', 'armGroupLabels': ['Intervention: Atherectomy']}, {'name': 'Stent', 'type': 'DEVICE', 'armGroupLabels': ['Intervention: Stents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Gu Yong Quan', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}