Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 10:51 AM
Study NCT ID:
NCT05894460
Status:
UNKNOWN
Last Update Posted:
2023-08-02
First Post:
2023-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 254}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-30', 'studyFirstSubmitDate': '2023-05-30', 'studyFirstSubmitQcDate': '2023-05-30', 'lastUpdatePostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary patency', 'timeFrame': '12 months', 'description': 'No occlusion or restenosis (\\>50%) of the target vessel in the treated segment during follow-up and no further intervention is required.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Femoral artery', 'Popliteal artery', 'Peripheral artery disease', 'Chocolate percutaneous transluminal angioplasty balloon', 'Drug-coated balloon'], 'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and efficacy of Chocolate balloons as a combination with drug-coated balloons in the treatment of popliteal artery lesions in lower limb atherosclerotic occlusive disease and will compare them with conventional balloons.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with femoropopliteal atherosclerotic occlusive disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rutherford classification of 2-6 in patients with femoropopliteal atherosclerotic occlusive disease;\n* primary cases with no previous surgical treatment of the target lesion;\n* presence of at least one vessel with patency in the distal outflow tract;\n* survival \\>1 year.\n\nExclusion Criteria:\n\n* planned stenting;\n* presence of flow-limiting dissection prior to application of Chocolate balloon and conventional balloon dilation of the target lesion;\n* combination of severe organ dysfunction of the heart, lungs and brain that cannot tolerate the procedure;\n* allergy to contrast agents, anaesthetic drugs, anticoagulants and anti-platelet drugs;\n* ineffective recanalization attempts;\n* lesions within or adjacent to the aneurysm, or the presence of a popliteal aneurysm.'}, 'identificationModule': {'nctId': 'NCT05894460', 'briefTitle': 'Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion: a Single-centre, Prospective Observational Study', 'orgStudyIdInfo': {'id': 'Chocolate-FP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chocolate balloon', 'interventionNames': ['Device: Chocolate balloon']}, {'label': 'Conventional ballon', 'interventionNames': ['Device: Chocolate balloon']}], 'interventions': [{'name': 'Chocolate balloon', 'type': 'DEVICE', 'description': 'Vascular preparation with chocolate balloons prior to drug-coated balloon angioplasty', 'armGroupLabels': ['Chocolate balloon', 'Conventional ballon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'None Selected', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhu Tong', 'role': 'CONTACT', 'email': 'tongzhuxw@163.com', 'phone': '13522419980'}], 'facility': 'Xuanwu Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}