Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-29 @ 6:38 AM
Study NCT ID:
NCT06288906
Status:
RECRUITING
Last Update Posted:
2025-05-01
First Post:
2024-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems
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': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Technical success', 'timeFrame': 'end of the surgical procedure', 'description': 'restore of vein patency with thrombus removal'}, {'measure': 'Number of Participants presenting Bleeding', 'timeFrame': '72 hours of mechanical thrombectomy treatment', 'description': 'Freedom from Major Bleeding'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thrombosis, Venous']}, 'referencesModule': {'references': [{'pmid': '35691538', 'type': 'BACKGROUND', 'citation': 'Jolly MA, Lockhart MM, Shah D, Huff CM, Valenti EA, Phillips JA, Bittar S, Botti CF, Kolluri R, Silver MJ. Outcomes from a tertiary care center using a catheter thrombectomy system for managing acute iliofemoral deep vein thrombosis. J Vasc Surg Venous Lymphat Disord. 2022 Sep;10(5):1044-1050. doi: 10.1016/j.jvsv.2022.04.010. Epub 2022 Jun 9.'}, {'pmid': '37981003', 'type': 'BACKGROUND', 'citation': 'Abramowitz S, Bunte MC, Maldonado TS, Skripochnik E, Gandhi S, Mouawad NJ, Mojibian H, Schor J, Dexter DJ; CLOUT study collaborators. Mechanical Thrombectomy vs. Pharmacomechanical Catheter Directed Thrombolysis for the Treatment of Iliofemoral Deep Vein Thrombosis: A Propensity Score Matched Exploratory Analysis of 12 Month Clinical Outcomes. Eur J Vasc Endovasc Surg. 2024 Apr;67(4):644-652. doi: 10.1016/j.ejvs.2023.11.017. Epub 2023 Nov 21.'}, {'pmid': '37580422', 'type': 'BACKGROUND', 'citation': 'Shaikh A, Zybulewski A, Paulisin J, Bisharat M, Mouawad NJ, Raskin A, Ichinose E, Abramowitz S, Lindquist J, Azene E, Shah N, Nguyen J, Cockrell J, Khalsa B, Khetarpaul V, Murrey DA Jr, Veerina K, Skripochnik E, Maldonado TS, Bunte MC, Annambhotla S, Schor J, Kado H, Mojibian H, Dexter D; CLOUT Investigators. Six-Month Outcomes of Mechanical Thrombectomy for Treating Deep Vein Thrombosis: Analysis from the 500-Patient CLOUT Registry. Cardiovasc Intervent Radiol. 2023 Nov;46(11):1571-1580. doi: 10.1007/s00270-023-03509-8. Epub 2023 Aug 14.'}]}, 'descriptionModule': {'briefSummary': 'This is a physician-initiated, observational, monocentric, retrospective and prospective Study. The study is intended to assess the feasibility of mechanical thrombectomy of caval and iliofemoral veins according to normal clinical practice in adult patients with symptomatic acute or subacute ileofemoral or caval deep vein thrombosis objectively diagnosed with CT scan imaging.', 'detailedDescription': 'Subjects with bilateral DVT may be enrolled, so long as the study limb(s) meet inclusion/exclusion criteria, including IVC patency. It is recommended that in a subject with bilateral DVT, central imaging be performed prior to treatment to evaluate the status of the IVC.\n\nAll the visits and procedures described will be performed according to the diagnostic and therapeutic assignment required by clinical practice for the patients under study. Therefore, the choice of assigning the patient to the diagnostic and therapeutic procedures deemed most appropriate for each case is completely independent of the study.\n\nAnticoagulation therapy with enoxaparin sodium (1 mg/kg twice a day) shall be initiated at least 48 hours prior to initiation of study treatment. Hemoglobin, INR, and platelet count must be obtained within 24 hours prior to the mechanical thrombectomy procedure in order to confirm eligibility. The access site is determined by the extent of occlusive disease. When treating a single limb at time, access via the popliteal vein is reasonable.\n\nUpon completion of study treatment, the catheter and sheath shall be removed and hemostasis obtained with pressure over the insertion site followed by placement of a pressure dressing. PCB shall remain placed on both legs until hospital discharge. Anticoagulation therapy with weight based enoxaparin sodium shall also be continued through discharge. The following assessments should be performed following the completion of study treatment, according to the normal clinical practice:\n\n* Duplex imaging (within 24 hours of the completion of treatment)\n* Laboratory tests (within 24 hours of the completion of treatment)\n* Collection of Adverse Events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Up to 50 patients (about 10 cases retrospective and 40 cases prospective) with symptomatic acute or subacute ileofemoral or caval deep vein thrombosis objectively diagnosed with CT scan imaging.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients admitted in the Unit of Vascular Surgery with proximal DVT (inferior vena cava, and/or iliac vein, and/or common femoral vein, and/or deep femoral vein, and/or femoral vein), according to ESVS guidelines (2022).\n\nExclusion Criteria:\n\n* Patient treated with thrombolysis drugs within 48 hours prior to the index procedure\n* Active bleeding, recent (\\<3 months) gastrointestinal (GI) bleeding, active peptic ulcer, severe liver dysfunction, and bleeding diathesis\n* Impossibility or refusal to give informed consent'}, 'identificationModule': {'nctId': 'NCT06288906', 'acronym': 'ASTER', 'briefTitle': 'Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems in a Monocentric, Observational Retrospective and Prospective Study (ASTER Study)', 'orgStudyIdInfo': {'id': 'ASTER Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Symptomatic deep vein thrombosis (DVT) patients', 'interventionNames': ['Other: mechanical thrombectomy of caval and iliofemoral veins']}], 'interventions': [{'name': 'mechanical thrombectomy of caval and iliofemoral veins', 'type': 'OTHER', 'description': 'investigate efficacy, safety of mechanical thrombectomy systems used in symptomatic acute and subacute ileofemoral and caval thrombosis', 'armGroupLabels': ['Symptomatic deep vein thrombosis (DVT) patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Domenico Baccellieri, Prof., MD', 'role': 'CONTACT', 'email': 'domenico.baccellieri@hsr.it', 'phone': '+39022643', 'phoneExt': '7377'}, {'name': 'Ilaria Controne', 'role': 'CONTACT', 'email': 'controne.ilaria@hsr.it', 'phone': '+39022643', 'phoneExt': '7141'}], 'facility': 'San Raffaele Hospital', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Baccellieri Domenico', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}