Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-28 @ 1:09 PM
Study NCT ID:
NCT06124768
Status:
RECRUITING
Last Update Posted:
2024-12-04
First Post:
2023-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D054070', 'term': 'Postthrombotic Syndrome'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014689', 'term': 'Venous Insufficiency'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-01', 'studyFirstSubmitDate': '2023-11-06', 'studyFirstSubmitQcDate': '2023-11-06', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immediate patency rate', 'timeFrame': 'Immediately after lonely percutaneous mechanical thrombectomy', 'description': 'Percentage of patency rate immediately after lonely percutaneous mechanical thrombectomy'}, {'measure': 'Incidence of post-thrombotic syndrome', 'timeFrame': '24-month', 'description': 'Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score'}], 'secondaryOutcomes': [{'measure': 'Rate of catheter-directed thrombolysis', 'timeFrame': 'Immediately after interventional surgery', 'description': 'Percentage of catheter-directed thrombolysis after mechanical thrombectomy'}, {'measure': 'Total time of interventional surgery', 'timeFrame': 'Immediately after interventional surgery', 'description': 'Total time measured by hours of interventional surgery (Including duration of subsequent catheter directed thrombolysis)'}, {'measure': 'Total dosage of urokinase', 'timeFrame': 'Immediately after interventional surgery', 'description': 'Total dosage measured by units of urokinase used for procedure'}, {'measure': 'Patency rate of lower limb vein', 'timeFrame': '24-month', 'description': 'Percentage of patency rate of lower limb vein evaluated by ultrasound'}, {'measure': 'Incidence of post-thrombotic syndrome', 'timeFrame': '12-month', 'description': 'Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score'}, {'measure': 'Re-intervention rate', 'timeFrame': '24-month', 'description': 'Percentage of re-intervention rate for the same limb'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deep venous thrombosis', 'Percutaneous mechanical thrombectomy', 'Post-thrombotic syndrome'], 'conditions': ['Deep Vein Thrombosis']}, 'descriptionModule': {'briefSummary': 'The study aims to compare the modified approach through ipsilateral deep calf venous access of contralateral femoral venous access with the traditional approach through ipsilateral popliteal venous access for mixed type deep venous thrombosis (DVT), and determine whether it can achieve similar therapeutic effects as central type DVT.', 'detailedDescription': 'Acute deep venous thrombosis (DVT) is associated with development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by percutaneous mechanical thrombectomy (PMT) may reduce the incidence of PTS. In general, PMT is performed through ipsilateral popliteal venous access as a traditional approach. However, the thrombosis in distal popliteal vein cannot be removed. Previous study demonstrated that the residual thrombus may decrease the efficacy of PMT. The study aims to compare the modified approach through ipsilateral deep calf venous access of contralateral femoral venous access with the traditional approach for mixed type DVT, and determine whether it can achieve similar therapeutic effects as central type DVT. The purpose of this study is to obtain high-level evidence for the endovascular treatment of acute DVT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute lower limb deep venous thrombosis (DVT) treated by percutaneous mechanical thrombectomy (PMT). The symptoms of DVT should no more than 14 days.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18-85 years old;\n2. Acute DVT occurred no more than 14 days since the onset of disease;\n3. DVT treated by percutaneous mechanical thrombectomy\n4. Informed consent signed by patients.\n\nExclusion Criteria:\n\n1. Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;\n2. Women during pregnancy and lactation;\n3. Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (\\<6 months);\n4. Patients who are unable or unwilling to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06124768', 'briefTitle': 'Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis (The CODA Study)', 'orgStudyIdInfo': {'id': 'The CODA study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mixed type DVT treated by PMT through the modified access', 'description': 'Anterograde venography shows patients with mixed type DVT. PMT is performed via ipsilateral distal calf venous access or contralateral femoral access.', 'interventionNames': ['Procedure: Percutaneous mechanical thrombectomy (PMT) by the modified approach']}, {'label': 'Mixed type DVT treated by PMT through the traditional access', 'description': 'Anterograde venography shows patients with mixed type DVT. PMT is performed via ipsilateral popliteal venous access.', 'interventionNames': ['Procedure: Percutaneous mechanical thrombectomy (PMT) by the traditional approach']}, {'label': 'Central type DVT treated by PMT', 'description': 'Anterograde venography shows patients with central type DVT. PMT is performed via any access, such as ipsilateral femoral venous access or ipsilateral popliteal venous access.', 'interventionNames': ['Procedure: Percutaneous mechanical thrombectomy (PMT) by the traditional approach']}], 'interventions': [{'name': 'Percutaneous mechanical thrombectomy (PMT) by the modified approach', 'type': 'PROCEDURE', 'description': 'The modified approach includes the ipsilateral calf venous access and the contralateral femoral venous access. Through contralateral femoral venous access, a hydrophilic guide wire and a catheter will be crossover through the thrombus side to the distal calf vein. The ipsilateral calf venous access will be punctured under the guidance of ascending venography. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is \\>50% stenosis of the diameter of the iliac vein.', 'armGroupLabels': ['Mixed type DVT treated by PMT through the modified access']}, {'name': 'Percutaneous mechanical thrombectomy (PMT) by the traditional approach', 'type': 'PROCEDURE', 'description': 'The traditional approach will be punctured from the ipsilateral popliteal vein under ultrasound guidance. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is \\>50% stenosis of the diameter of the iliac vein.', 'armGroupLabels': ['Central type DVT treated by PMT', 'Mixed type DVT treated by PMT through the traditional access']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ni Qihong, M.D.', 'role': 'CONTACT', 'email': 'niqihong1989@163.com', 'phone': '+86 15801900772'}], 'facility': 'Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ni Qihong, M.D.', 'role': 'CONTACT', 'email': 'niqihong1989@163.com', 'phone': '+8615801900772'}], 'overallOfficials': [{'name': 'Ni Qihong, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, {'name': 'Chengdu University of Traditional Chinese Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}