Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-31 @ 4:37 PM
Study NCT ID:
NCT04982367
Status:
UNKNOWN
Last Update Posted:
2023-10-18
First Post:
2021-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 166}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-16', 'studyFirstSubmitDate': '2021-07-21', 'studyFirstSubmitQcDate': '2021-07-21', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary patency rate of target lesion at 12 months post-procedure', 'timeFrame': '12 months post-procedure', 'description': 'Defined as freedom from clinically driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4)'}], 'secondaryOutcomes': [{'measure': 'Rate of device success', 'timeFrame': 'immediate post-procedure', 'description': 'Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)'}, {'measure': 'Rate of clinically driven target lesion revascularization (CD-TLR) at 12 months post-procedure', 'timeFrame': '12 months post-procedure', 'description': 'Defined as any reintervention at the target lesion due to symptoms or the following index: drop of ABI \\>20% or ABI \\>0.15 compared to the post-procedure ABI during 12 months post-procedure'}, {'measure': 'The change of Rutherford class from baseline', 'timeFrame': '12 months post-procedure', 'description': 'Defined as change in target limb Rutherford class from baseline to 12 months'}, {'measure': 'The change of ankle-brachial index (ABI) from baseline', 'timeFrame': '12 months post-procedure', 'description': 'Defined as change of target limb ABI from baseline to 12 months'}, {'measure': 'Rate of composite safety endpoint', 'timeFrame': '30 days post-procedure', 'description': 'Defined a composite rate of device-related or procedure-related death, major target limb amputation (above-the-ankle amputation), clinically driven target lesion revascularization (CD-TLR) or target lesion thrombotic events through 30 days post- procedure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug eluting balloon catheter', 'Peripheral Artery Disease'], 'conditions': ['Peripheral Artery Disease']}, 'descriptionModule': {'briefSummary': 'A prospective randomized trial designed to compare the efficacy and safety of Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old and ≤80 years old\n* Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5\n* SFA and/or popliteal artery had severe stenosis (stenosis degree ≥70%) or occlusion.\n* The length of target lesion less than 20 cm\n* Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed\n\nExclusion Criteria:\n\n* The plasma creatinine level is higher than 150 umol/L\n* Thrombolysis or thrombectomy is required\n* There are more than 2 lesion need to treat in the target vessel.\n* The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.\n* The target lesion had residual stenosis\\>30% or flow-limit dissection after pre-dilatation.\n* The patient had outflow less than 1 vessel\n* The lesion located in a stent.\n* Patient has a known allergy to aspirin, clopidogrel, heparin, paclitaxel, sirolimus or contrast medium that cannot be adequately pre-medicated.\n* Women who are pregnant or breast-feeding.\n* The subjects have participated in other drug property studies or device studies that have not yet completed the main end point.\n* Patient has life expectancy of less than 12 months.\n* The investigator think the patient is not suitable for participation in the clinical trial.'}, 'identificationModule': {'nctId': 'NCT04982367', 'briefTitle': 'Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acotec Scientific Co., Ltd'}, 'officialTitle': 'A Prospective, Multicenter, Randomized Controlled Trial Comparing the Efficacy and Safety Between Sirolimus Coated Balloon Catheter and Paclitaxel Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis.', 'orgStudyIdInfo': {'id': 'Acoart SCB SFA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sirolimus-eluting balloon angioplasty', 'description': 'Using Sirolimus Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery', 'interventionNames': ['Device: Sirolimus-eluting balloon catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paclitaxel-eluting balloon angioplasty', 'description': 'Using Paclitaxel Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery', 'interventionNames': ['Device: Paclitaxel-eluting balloon catheter']}], 'interventions': [{'name': 'Sirolimus-eluting balloon catheter', 'type': 'DEVICE', 'otherNames': ['Sirolimus coated balloon catheter'], 'description': 'Sirolimus-eluting balloon catheter designed and produced by Acotec', 'armGroupLabels': ['Sirolimus-eluting balloon angioplasty']}, {'name': 'Paclitaxel-eluting balloon catheter', 'type': 'DEVICE', 'otherNames': ['Paclitaxel coated balloon catheter'], 'description': 'Paclitaxel-eluting balloon catheter (trade name:DHALIA)', 'armGroupLabels': ['Paclitaxel-eluting balloon angioplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100039', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Guo, MD', 'role': 'CONTACT', 'email': 'pla301dml@vip.sina.com', 'phone': '010-66887329'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Guo Wei, MD', 'role': 'CONTACT', 'email': 'pla301dml@vip.sina.com', 'phone': '010-66887329'}], 'overallOfficials': [{'name': 'Guo Wei, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acotec Scientific Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}