Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-31 @ 3:04 AM
Study NCT ID:
NCT01171703
Status:
UNKNOWN
Last Update Posted:
2012-12-24
First Post:
2010-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part I)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007511', 'term': 'Ischemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015607', 'term': 'Stents'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-20', 'studyFirstSubmitDate': '2010-07-26', 'studyFirstSubmitQcDate': '2010-07-27', 'lastUpdatePostDateStruct': {'date': '2012-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occlusion of the stent or bypass', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure.'}, {'measure': 'Rate of limb salvage', 'timeFrame': '36 months'}, {'measure': 'Procedural complications, defined as any adverse event', 'timeFrame': '36 months', 'description': 'including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula'}, {'measure': 'Quality of Life assessment', 'timeFrame': '36 months', 'description': 'assessment in 1 month,6 months,12 months,24 months and 36 months post procedure'}, {'measure': 'Restenosis measured by Duplex Ultrasound or CTA', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Critical limb ischemia', 'Diabetes', 'Femoropopliteal artery bypass', 'Stent'], 'conditions': ['Vascular Diseases', 'Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.vascular.cn/', 'label': 'the website of the vascular surgery department of PUMCH'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to find out the appropriate way to treat DM patients with critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion.', 'detailedDescription': 'The trial includes two parts and here is part I. This part is a multi-center, prospective, randomized, controlled study to compare the therapeutic effect of stent and bypass to chronic long occlusion of the superficial femoral artery in DM patients. Totally 70 patients will be entered into the study. The lesion of the femoral artery should be TASC B、C or D and the patients should suffered ischemic symptom with Rutherford 3-6.The lesion does not extend beyond the aortoiliac artery or blow-knee popliteal artery, with at least 1 vessel infra-popliteal runoff to the foot.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients volunteer to join the trial and sign the formal consent.\n* The patients are ≥55 year-old and ≤75 year-old.\n* The patients suffer from symptomatic leg ischemia with rutherford classification3, 4 , 5 or 6. The presentation is severe intermittent claudication, rest pain, ulcer or gangrene.\n* The lesion of the femoral artery should be TASC B、C or D.\n* The femoral-popliteal artery has never received bypass or endovascular therapy before.\n* No obvious stenosis or occlusion in the aortoiliac artery; or the lesion could be treated simultaneously or has already been cured.\n* No obvious stenosis in below-knee popliteal artery; at least 1 vessel infra-popliteal runoff to the foot.\n* No surgical contraindications;no infection in operation region.\n* Be diagnosed with DM for at least 1 year.\n\nExclusion Criteria:\n\n* Refuse random treatment.\n* Previous operations on the superficial femoral artery.\n* Acute lower extremity arterial thrombosis.\n* Serious major organ failure.\n* Allergic to the contrast agent or has contrast nephropathy.\n* No clinical compliance or unfit to join the trial'}, 'identificationModule': {'nctId': 'NCT01171703', 'acronym': 'DCLI-I', 'briefTitle': 'Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part I)', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part I)', 'orgStudyIdInfo': {'id': 'pumch-DCLI-I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bypass', 'description': 'femoral-popliteal bypass', 'interventionNames': ['Device: femoral-popliteal bypass']}, {'type': 'EXPERIMENTAL', 'label': 'stent', 'interventionNames': ['Device: stent']}], 'interventions': [{'name': 'femoral-popliteal bypass', 'type': 'DEVICE', 'description': 'Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.', 'armGroupLabels': ['bypass']}, {'name': 'stent', 'type': 'DEVICE', 'description': 'Before operation, take aspirin 100mg every day. During the operation, stent is delivered by a catheter and positioned through the narrowing in the artery. The stent is then expanded against the wall of the blood vessel to provide a wider channel for blood. At last, use balloon dilate the stent.', 'armGroupLabels': ['stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xuanwu Hospital, Beijing', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tongren Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Liu changwei, bachelor', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}, {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vascular Surgery', 'investigatorFullName': 'Liu Chang-wei', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}