Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-02-09 @ 6:42 PM
Study NCT ID:
NCT05415995
Status:
UNKNOWN
Last Update Posted:
2022-06-13
First Post:
2022-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases
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': 202}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-10', 'studyFirstSubmitDate': '2022-06-06', 'studyFirstSubmitQcDate': '2022-06-10', 'lastUpdatePostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change of Ankle-Branchial Index(ABI)', 'timeFrame': '180 days', 'description': 'ABI is a simple measurement identifies unrecognized Peripheral Arterial Disease.'}, {'measure': 'The rate of target lesion revascularization(TLR)', 'timeFrame': '30 days/ 180 days', 'description': 'TLR is defined as revascularization of the target lesion with stenosis ≥70%.'}], 'primaryOutcomes': [{'measure': 'Rate of primary patency of the target lesion', 'timeFrame': '180 days', 'description': 'Primary patency is defined as no target lesion occlusion, no clinical symptom driven target lesion revascularization and major limb amputation.'}], 'secondaryOutcomes': [{'measure': 'Success rate of the device', 'timeFrame': 'Intraoperation', 'description': 'Success rate of the device is defined as a situation that the balloon catheter reached the lesion site, dilated successfully without rupture, and was successfully withdrawn.'}, {'measure': 'Success rate of the technique', 'timeFrame': 'Immediately after the intervention', 'description': 'On the basis of device success,technique success rate is defined as restored blood flow in the lesion after the treatment, and the residual stenosis ≤30%.'}, {'measure': 'Success rate of the operation', 'timeFrame': 'Within 7 days', 'description': 'On the basis of technique success, operation success is defined as no adverse event happening.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Artery Disease']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.', 'detailedDescription': 'This trail is conducted in several centers all around China. 202 subjects with below the knee arterial stenosis or occlusion will be recruited and randomized, this trail compares the efficacy and safety of Drug-coated Balloon (Zylox-Tonbridge) with a similar balloon catheter producted by Acotec. The subjects will be followed up when discharged /in 30 days/ 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-85 years；\n* ≥70% diameter stenosis or occlusion in the target below-the-knee lesion；\n* Rutherford Category 3-6；\n* Subjects are willing to sign informed consent；\n\nExclusion Criteria:\n\n* Planned major limb amputation within 30 days after the procedure;\n* In-stent stenosis in the target lesion;\n* Severely calcified target lesions；\n* Creatinine\\>2.5mg/dL;\n* History of allergies to anesthetics, contrast agents；\n* Subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint；\n* Other circumstances judged by researchers that are not suitable for enrollment."}, 'identificationModule': {'nctId': 'NCT05415995', 'briefTitle': 'A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zhejiang Zylox Medical Device Co., Ltd.'}, 'officialTitle': 'A Prospective, Multicenter, Randomized Controlled Trail Using Drug-coated Balloon to Treat Below The Knee Arterial Stenosis or Occlusion', 'orgStudyIdInfo': {'id': 'V1.1/2021-12-25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '101 Patients with Below The Knee Artery stenosis or occlusion in Experimental Group', 'description': 'Patients in this group use Drug eluting Balloon (Zylox-tonbridge), this is the product to be test in this clinical trail. The drug we coated is paclitaxel.', 'interventionNames': ['Device: Drug eluting Balloon']}, {'type': 'ACTIVE_COMPARATOR', 'label': '101 Patients with Below The Knee Artery stenosis or occlusion in Controlled Group', 'description': 'Patients in this group use Drug eluting Balloon(Acotec), this is a product that has got approved by NMPA in 2016.', 'interventionNames': ['Device: Drug eluting Balloon']}], 'interventions': [{'name': 'Drug eluting Balloon', 'type': 'DEVICE', 'description': 'Drug eluting Balloon is a kind of the product that has been used for many years. By filling the micropores on the surface of the balloon with anti-proliferative drugs like immunosuppressive agents, the balloon is expanded and contacted with the lesion to rapidly release the drug to the local arterial wall.', 'armGroupLabels': ['101 Patients with Below The Knee Artery stenosis or occlusion in Controlled Group', '101 Patients with Below The Knee Artery stenosis or occlusion in Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shengyun Wan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The second hospital of Anhui Medical university', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Xiamen', 'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojin Huang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoming Shi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hebei General Hospital', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuiting Zhai', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "HeNan Province People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhen Li', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital Of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tao He', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The central hospital of Wuhan', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoqiang Li', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nanjing Drum Tower Hospital, the affiliated hospital of Nanjing University medical school', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Dalian', 'state': 'Liaoning', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital Of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Jiang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'General Hospital of Northern Theater Command', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Qingdao', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mingjin Guo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The affiliated Hospital of QingDao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wendong Cao', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanxi Bethune Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Luzhou', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The affiliated hospital of southwest medical university', 'geoPoint': {'lat': 28.8903, 'lon': 105.42575}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangchen Dai', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xupin Xie', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Affiliated HangZhou First People's Hospital, Zhejiang University School of medicine", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Ningbo', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dehai Lang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Huamei hospital, University of Chinese academy of sciences', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'DongZhi Ye', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'YingHua Zou', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junmin Bao', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Minyi Yin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jie Liang', 'role': 'CONTACT', 'email': 'jie.liang@zyloxmedical.com', 'phone': '13819565660'}], 'overallOfficials': [{'name': 'Junmin Bao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Zylox Medical Device Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}