Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-04 @ 4:55 PM
Study NCT ID:
NCT06468150
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2024-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanical Thrombectomy and Catheter Directed Thrombolysis Utilization in Patients With Deep Vein Thrombosis
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2427}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-16', 'studyFirstSubmitDate': '2024-06-12', 'studyFirstSubmitQcDate': '2024-06-16', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with deep vein thrombosis who could be eligible for mechanical thrombectomy and catheter-directed thrombolysis', 'timeFrame': 'from date of admission until the date of discharge, up to 1-2 weeks', 'description': 'The number of participants with deep vein thrombosis who would fit the eligibility criteria for performing the intervention'}], 'secondaryOutcomes': [{'measure': 'The number of patients with deep vein thrombosis who underwent mechanical thrombectomy and catheter-directed thrombolysis', 'timeFrame': 'from date of admission until the date of discharge, up to 1-2 weeks', 'description': 'The number of participants with deep vein thrombosis who fitted the eligibility criteria and underwent the intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mechanical thrombectomy', 'catheter directed thrombolysis', 'iliofemoral deep vein thrombosis'], 'conditions': ['Deep Vein Thrombosis']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to assess the utilization of mechanical thrombectomy and catheter-directed thrombolysis in patients with deep vein thrombosis in tertiary care. The main questions it aims to answer are:\n\n1. How many patients with deep vein thrombosis are potentially eligible for mechanical thrombectomy and catheter-directed thrombolysis in a tertiary hospital?\n2. What is the actual number of patients undergoing endovascular interventions for deep vein thrombosis?\n\nParticipants received endovascular treatment according to the clinical protocol of the treatment.', 'detailedDescription': 'Tertiary hospital database was analyzed. All the records of patients referred for deep vein thrombosis were extracted. The collected data included general patient information, medical history, results of physical examination, duplex ultrasound, laboratory analysis, etc. Indications and contraindications for mechanical thrombectomy and catheter-directed thrombolysis were assessed, considering possible benefits and risks. Patients who could be eligible for this technique were identified'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with deep vein thrombosis referred to the hospital from January 2022 to December 2023.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* lower limb, pelvic, or inferior vena cava deep vein thrombosis\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06468150', 'briefTitle': 'Mechanical Thrombectomy and Catheter Directed Thrombolysis Utilization in Patients With Deep Vein Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Pirogov Russian National Research Medical University'}, 'officialTitle': 'Mechanical Thrombectomy and Catheter Directed Thrombolysis Utilization in Patients With Deep Vein Thrombosis', 'orgStudyIdInfo': {'id': '224/22'}}, 'contactsLocationsModule': {'locations': [{'zip': '117997', 'city': 'Moscow', 'country': 'Russia', 'facility': 'The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pirogov Russian National Research Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery, Pirogov RNRMU, Zolotukhin Igor Anatolievich', 'investigatorFullName': 'Igor Zolotukhin', 'investigatorAffiliation': 'Pirogov Russian National Research Medical University'}}}}