Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-30 @ 6:35 AM
Study NCT ID:
NCT05158257
Status:
UNKNOWN
Last Update Posted:
2022-10-12
First Post:
2021-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-09', 'studyFirstSubmitDate': '2021-10-07', 'studyFirstSubmitQcDate': '2021-12-02', 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '12-month Primary Patency Rate', 'timeFrame': '12 months', 'description': 'systolic velocity ratio \\>2.4 as measured by Duplex ultrasound.'}], 'secondaryOutcomes': [{'measure': 'Technical success rate', 'timeFrame': '1 day', 'description': 'Technical success was defined as residual stenosis less than 30% by final'}, {'measure': 'freedom from clinically-driven TLR rate', 'timeFrame': '12 months', 'description': 'it is defined as the freedom from clinically-driven target lesion revascularization'}, {'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.'}, {'measure': '12-month Limb Salvage Rate', 'timeFrame': '12 months', 'description': 'Limb Salvage is defined as the freedom from secondary major amputation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stent', 'debulking', 'femoral artery', 'drug-coated balloon'], 'conditions': ['Atherosclerosis', 'Ischemia']}, 'descriptionModule': {'briefSummary': 'This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between endovascular debulking combined drug-coated balloon and balloon dilatation combined stent angioplasty in treatment of femoral-popliteal artery lesions.', 'detailedDescription': 'Prospective randomized controlled study to evaluate the difference of safety，effectiveness between endovascular debulking combined drug-coated balloon and balloon dilatation combined stent angioplasty in treatment of femoral-popliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the endovascular debulking combined drug-coated balloon group and balloon dilatation combined with stent angioplasty group. Compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments. At the same time, the peri-operative related factors that may affect the end point events, such as preoperative baseline data, lesion characteristics, imaging features, stent fracture, and end point observation indexes were analyzed by regression analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria： 1.all patients signed an informed consent form; 2.digital subtraction angiography (DSA) revealed femoropopliteal artery stenosis above 70% or occlusion resulting in claudication (Rutherford clinical category-Becker class II-III2-3) or critical limb ischemia (CLI) (Rutherford clinical category 4-5-Becker class IV-V) 3.with unobstructed vascular inflow; 4.with at least a vessel runoff; 5. good compliance and regular follow-up.\n\nExclusion criteria: 1. Acute or subacute lower limb ischemia caused by acute intraluminal thrombus within the target lesion.; 2. Severe calcified lesions （grade 4 in the PACSS scale）; 3. In-stent restenosis lesion or surgical arterial bypass grafting; 4. Severe renal insufficiency: creatinine level greater than 2.5 mg/dL; 5. Platelet count below 100,000/μL or with antiplatelet / anticoagulation contraindications; 6. Immunologic diseases or malignant diseases; 7. Ongoing active infection; 8. Decompensated congestive heart failure or acute coronary syndrome; 9. Refuse to sign the informed consent Unwillingness to comply with follow-up suggestions.'}, 'identificationModule': {'nctId': 'NCT05158257', 'briefTitle': 'Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity', 'orgStudyIdInfo': {'id': 'XuanwuH202110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention: balloon and Stents', 'description': 'plain balloon and Stents group', 'interventionNames': ['Device: balloon and Stent']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention: debulking and drug coated balloon', 'description': 'debulking and drug coated balloon group', 'interventionNames': ['Device: endovascular debulking and DCB']}], 'interventions': [{'name': 'balloon and Stent', 'type': 'DEVICE', 'description': 'balloon dilatation combined stent angioplasty', 'armGroupLabels': ['Intervention: balloon and Stents']}, {'name': 'endovascular debulking and DCB', 'type': 'DEVICE', 'description': 'endovascular debulking combined drug-coated balloon', 'armGroupLabels': ['Intervention: debulking and drug coated balloon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian ming Guo, M.D.', 'role': 'CONTACT', 'email': 'guojianming@aliyun.com', 'phone': '13146369562'}, {'name': 'Yong quan Gu, M.D.', 'role': 'CONTACT', 'email': '15901598209@163.com', 'phone': '15901598209'}], 'facility': 'Gu Yong Quan', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'yang Li, M.D.', 'role': 'CONTACT', 'email': 'liyang0603@aliyun.com', 'phone': '18810432268'}, {'name': 'Yong quan Gu, M.D.', 'role': 'CONTACT', 'email': '15901598209@163.com', 'phone': '15901598209'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}