Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-03-02 @ 10:05 PM
Study NCT ID:
NCT06472518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2029-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2024-06-24', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost-utility analysis', 'timeFrame': '30 month', 'description': 'Cost-utility analysis of the economic efficiency of the PMT strategy compared with the anticoagulation strategy for the treatment of DVT from a collective perspective and a 30-month time horizon'}], 'secondaryOutcomes': [{'measure': 'Number of patients with Villalta score greater than or equal to 10', 'timeFrame': '30 month', 'description': 'Number of patients with Villalta score greater than or equal to 10'}, {'measure': 'Number of patients with Villalta score greater than or equal to 15, or presence of ulceration', 'timeFrame': '30 month', 'description': 'Number of patients with Villalta score greater than or equal to 15, or presence of ulceration'}, {'measure': 'Number of major hemorrhages and number of clinically relevant non-major hemorrhages according to ISTH criteria', 'timeFrame': '1, 30 and 60 month', 'description': 'Number of major hemorrhages and number of clinically relevant non-major hemorrhages according to ISTH criteria'}, {'measure': 'Number of patients with pain greater than or equal to 7 as assessed by the visual analog scale, or the presence of venous claudication, or lower-limb edema with a circumference greater than 20% of the contralateral leg, or failure to return to work.', 'timeFrame': '1 month', 'description': 'Number of patients with pain greater than or equal to 7 as assessed by the visual analog scale, or the presence of venous claudication, or lower-limb edema with a circumference greater than 20% of the contralateral leg, or failure to return to work.'}, {'measure': 'VEIN-QOL', 'timeFrame': '1,30 and 60 month', 'description': 'overall assessment by questionnaire'}, {'measure': 'CIVIQ 20', 'timeFrame': '1,30 and 60 month', 'description': 'score 0 to 100'}, {'measure': 'SF36 scores', 'timeFrame': '1,30 and 60 month', 'description': 'score 0 to 100'}, {'measure': 'Number of patients with onset of venous claudication', 'timeFrame': '30 month', 'description': 'Number of patients with onset of venous claudication'}, {'measure': 'Number of patients with a trophic disorder, assessed by clinical examination', 'timeFrame': '60 month', 'description': 'Number of patients with a trophic disorder, assessed by clinical examination'}, {'measure': 'Incremental cost-utility ratio of MPT compared with anticoagulation strategy', 'timeFrame': '60 month', 'description': 'Incremental cost-utility ratio of MPT compared with anticoagulation strategy'}, {'measure': 'Net financial impact over 5 years of TPM distribution', 'timeFrame': '60 month', 'description': 'Net financial impact over 5 years of TPM distribution'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iliofemoral Venous Thrombosis']}, 'descriptionModule': {'briefSummary': '* Iliofemoral DVTs (IF DVTs) are vascular disorders associated with high morbidity and mortality, which can be complicated by long-term post-thrombotic syndrome (PTS).\n* Pharmaco mechanical thrombolysis (PMT) is an innovative endovascular technique involving in situ fibrinolysis of the thrombus in the acute phase of thrombosis, followed by mechanical extraction by fragmenting the thrombus.\n* The American ATTRACT study showed that management by catheter-directed thrombolysis and/or PMT in the acute phase is safe and effective at 2 years in a subgroup of DVTif compared with anticoagulation (18% moderate or severe SPT with thrombolysis vs. 28% without thrombolysis).\n* PMT-DVT will be the first study to assess the medium (30 months) and long-term (60 months) efficacy of PMT in the French context, using data from the French National Health Data System.', 'detailedDescription': 'Patients with acute iliofemoral thrombosis will be included in the study after consent. They will be randomized to pharmaco-mechanical thrombolysis combined with anticoagulant therapy with direct oral anticoagulant versus direct anticoagulant therapy alone. They will be monitored, and patients in the anticoagulation-only group may undergo stenting angioplasty in the chronic phase if they present a moderate post-thrombotic syndrome or venous claudication. At the end of 30 months, a medico-economic analysis will be carried out.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who agreed to participate in the study and gave oral consent.\n* Patient affiliated to a social security scheme\n* Iliac and/or common femoral venous thrombosis\n* Recent thrombosis less than or equal to 14 days since qualifying imaging or less than or equal to 21 days since onset of symptoms\n\nAnd at least 1 of the following criteria:\n\n* Visual analog scale greater than or equal to 5 and/or\n* Venous claudication and/or\n* Increase in thigh circumference greater than or equal to 5% compared with contralateral thigh.\n\nExclusion Criteria:\n\n* Patients with superficial femoral or popliteal venous thrombosis without involvement of the common femoral or iliac veins.\n* Patients with isolated thrombosis of the inferior vena cava, without extension to the iliac veins.\n* Thrombosis of inferior vena cava proximal to the renal veins.\n* Minors, pregnant women, adults under guardianship.\n* Chronic renal failure with creatinine clearance below 30ml/min according to Cockroft.\n* Ischaemic phlebitis: proximal venous thrombosis associated with limb ischemia and impaired arterial flow.'}, 'identificationModule': {'nctId': 'NCT06472518', 'acronym': 'PMT-DVT', 'briefTitle': 'Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Prospective Randomised Multicentre Medico-economic Evaluation of Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs.', 'orgStudyIdInfo': {'id': 'RC22_0472'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pharmaco mechanical thrombolysis', 'description': 'thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants', 'interventionNames': ['Device: pharmaco mechanical thrombolysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'oral anticoagulant alone', 'description': 'a reference treatment arm for patients receiving direct oral anticoagulant alone and stenting angioplasty in case of venous claudication or moderate post-thrombotic syndrome six months after the initial thrombosis.', 'interventionNames': ['Device: pharmaco mechanical thrombolysis']}], 'interventions': [{'name': 'pharmaco mechanical thrombolysis', 'type': 'DEVICE', 'description': 'arm with the pharmaco mechanical thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants', 'armGroupLabels': ['oral anticoagulant alone', 'pharmaco mechanical thrombolysis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Olivier Espitia, Dr', 'role': 'CONTACT', 'email': 'olivier.espitia@chu-nantes.fr', 'phone': '02 40 08 33 55'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}