Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT05356767
Status:
RECRUITING
Last Update Posted:
2022-05-11
First Post:
2022-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Study of Percutaneous Mechanical Thrombectomy Treating Acute Deep Vein Thrombosis of Lower Extremities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2022-04-27', 'studyFirstSubmitQcDate': '2022-04-27', 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower extremity deep vein patency rate 6 months after operation', 'timeFrame': '6 months', 'description': 'The patency of the lower extremity veins was assessed by lower extremity venous ultrasound or lower extremity venography.'}, {'measure': 'Incidence of sequelae of deep venous thrombosis after PMT', 'timeFrame': '24 months', 'description': 'According to the postoperative symptoms and signs of the patients, the Villata score, (VEINS QoL)/Sym questionnaire and VCSS score were used to understand the PTS situation.'}], 'secondaryOutcomes': [{'measure': 'Total duration of interventional treatment', 'timeFrame': '1 day', 'description': 'Including the entire operation time of interventional surgery'}, {'measure': 'Total urokinase dosage', 'timeFrame': '1 day', 'description': 'interventional surgery urokinase dosage'}, {'measure': 'Lower extremity deep venous patency rate of patients before discharge', 'timeFrame': '1 week', 'description': 'The patency rate of lower extremity deep veins in patients 1 week after operation'}, {'measure': 'Postoperative quality of life score (QOL)', 'timeFrame': '6 months,12 months,18 months and 24 months', 'description': 'Postoperative quality of life scoring using the QOL scale'}, {'measure': 'reoperation rate', 'timeFrame': '6 months,12 months,18 months and 24 months', 'description': 'Reoperation due to thrombosis, pts'}, {'measure': 'Incidence of bleeding complications', 'timeFrame': '1day，7day，3 months', 'description': 'Symptoms of perioperative hemorrhage'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacomechanical thrombolysis', 'Deep vein thrombosis', 'post-thromboticsyndrome'], 'conditions': ['Pharmacomechanical Thrombolysis', 'Deep Vein Thrombosis']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, multicenter, real world, observational study intended to understand tmechanical thrombectomy in the treatment of acute deep venous thrombosis of lower extremities, It is estimated that 600 patients with DVT were enrolled in the group at 24 centers nationwide from May 2022 to May2024. we can obtain data on the incidence of sequelae of deep venous thrombosis after PMT, and analyze the factors that may affect the efficacy of PMT.', 'detailedDescription': 'Through inclusion and exclusion criteria, 600 patients were collected. This experiment was an observational study case series, and no control group was established. The patency of the lower extremity veins was assessed by lower extremity venous ultrasound or lower extremity venography. According to the postoperative symptoms and signs of the patients, the Villata score, (VEINS QoL)/Sym questionnaire and VCSS score were used to understand the PTS situation.Postoperative clinical follow-up was performed at 6 months, 12 months, 18 months, and 24 months. The main endpoints were the patency rate of lower extremity deep veins at 6 months after operation and the incidence of PTS (Villalta score) at 2 years after operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Deep vein thrombosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The symptoms of deep venous thrombosis of lower extremities occurred within 14 days (including 14 days)；\n2. Lower extremity deep venous thrombosis involving iliac vein or / and femoral vein ;\n3. Obtain the informed consent of all patients.\n\nExclusion Criteria:\n\n1. Patients with a previous history of ipsilateral proximal lower limb deep venous thrombosis ;\n2. patients who are prohibited from thrombolytic therapy;\n3. inferior vena cava compression syndrome；\n4. Allergic to heparin, low molecular weight heparin or contrast medium;\n5. Patients who have participated in clinical trials of other drugs or medical devices that interfere with this clinical trial in the past 3 months;\n6. Patients who do not want to participate in this trial;\n7. Patients with poor compliance, or those who the researchers think are not suitable for selection.'}, 'identificationModule': {'nctId': 'NCT05356767', 'briefTitle': 'The Study of Percutaneous Mechanical Thrombectomy Treating Acute Deep Vein Thrombosis of Lower Extremities', 'organization': {'class': 'OTHER', 'fullName': 'Chengdu University of Traditional Chinese Medicine'}, 'officialTitle': 'the Director of Vascular Surgery of Hospital of Chengdu University of Traditional Chinese Medicine', 'orgStudyIdInfo': {'id': 'ChengduUTCMvs3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'post-thromboticsyndrome', 'description': 'suffering from PTS (Villalta score) at 2 years after operation.', 'interventionNames': ['Procedure: Pharmacomechanical thrombolysis']}, {'label': 'n-post-thromboticsyndrome', 'description': 'none of PTS (Villalta score) at 2 years after operation.', 'interventionNames': ['Procedure: Pharmacomechanical thrombolysis']}], 'interventions': [{'name': 'Pharmacomechanical thrombolysis', 'type': 'PROCEDURE', 'description': 'Pharmacomechanical thrombolysis', 'armGroupLabels': ['n-post-thromboticsyndrome', 'post-thromboticsyndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunshui He, Doctor', 'role': 'CONTACT', 'email': 'chunshuihe@msn.com', 'phone': '86-18981885601'}, {'name': 'Wei Huang, Master', 'role': 'CONTACT', 'email': '254652468@qq.com', 'phone': '86-18008068144'}], 'facility': 'Chunshuihe', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Chunshui He, doctor', 'role': 'CONTACT', 'email': 'chunshuihe@msn.com', 'phone': '86-18981885601', 'phoneExt': '028-87766214'}, {'name': 'Wei Huang, master', 'role': 'CONTACT', 'email': '254652468@qq.com', 'phone': '86-18008068144', 'phoneExt': '028-87766214'}], 'overallOfficials': [{'name': 'Meng Ye, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator RenJi Hospital'}, {'name': 'Ziheng Wu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator Zhejiang University'}, {'name': 'Lianrui Guo, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator Xuanwu Hospital, Beijing'}, {'name': 'Xin Fang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Study Principal Investigator Hangzhou first people's Hospital of Medical College of Zhejiang University"}, {'name': 'Hongfei Sang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator Second Affiliated Hospital of Suzhou University'}, {'name': 'Qiang Li, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator Qingdao Haici Hospital affiliated to Qingdao University'}, {'name': 'Zibo Feng, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology'}, {'name': 'Zhenyu Shi, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Zhongshan Hospital'}, {'name': 'Weihao Shi, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital'}, {'name': 'Wensheng Lou, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital With Affiliated Nanjing Medical University'}, {'name': 'Hui Zhao, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital of Nantong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'the director of the vascular surgery of Hospital of Chengdu University of Traditional Chinese Medicine', 'investigatorFullName': 'Chunshui He', 'investigatorAffiliation': 'Chengdu University of Traditional Chinese Medicine'}}}}