Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT05794932
Status:
COMPLETED
Last Update Posted:
2025-05-30
First Post:
2023-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054070', 'term': 'Postthrombotic Syndrome'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}], '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'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2023-03-17', 'studyFirstSubmitQcDate': '2023-03-31', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VO2 max', 'timeFrame': 'From baseline and 8 weeks', 'description': 'Change in VO₂ max is the maximum (max) rate (V) of oxygen (O₂) the body is able to use during exercise from baseline to 8 weeks. It is measured in liters of O2 per minute'}], 'secondaryOutcomes': [{'measure': 'Maximum aerobic power (in Watts)', 'timeFrame': 'From baseline and 8 weeks', 'description': 'Maximum aerobic power is measured in watts before and after venous recanalization'}, {'measure': 'Isowork power', 'timeFrame': 'From baseline and 8 weeks', 'description': "The isowork power is the power output assessed at the V'O2max before recanalization"}, {'measure': 'Maximal exercise cardiac output (in litres per minute)', 'timeFrame': 'From baseline and 8 weeks', 'description': 'Maximal exercise cardiac output is the cardiac output assessed by thoracic impedance et peak exercise before and after venous recanalization'}, {'measure': 'Exercise change in Inspiratory capacity (in litres)', 'timeFrame': 'From baseline and 8 weeks', 'description': 'Exercise change in Inspiratory capacity is the change between rest and peak exercise of the inspiratory capacity (the volume between end-expiratory volume and total lung capacity) before and after venous recanalization'}, {'measure': 'Maximal exercise capillary volume (in millilitres)', 'timeFrame': 'From baseline and 8 weeks', 'description': 'Maximal exercise capillary volume is the capillary volume at peak exercise assessed by NO/CO transfer before and after venous recanalization'}, {'measure': 'Maximal exercise O2 arterial pressure (PaO2, in mmHg)', 'timeFrame': 'From baseline and 8 weeks', 'description': 'Maximal exercise O2 arterial pressure is the oxygen partial pressure in the arterial blood, assessed at peak exercise, before and after venous recanalization'}, {'measure': 'Maximal isometric torque during leg extension (in Newton.meters)', 'timeFrame': 'From baseline and 8 weeks', 'description': 'Maximal isometric strength during leg extension is the maximal torque of the leg extension at 90° knee flexion assessed by a torque sensor before and after venous recanalization'}, {'measure': 'Lower limb extracellular/total water (in %)', 'timeFrame': 'From baseline and 8 weeks', 'description': 'Lower limb extracellular/total water is the water volume int the body compartments in each lower limb, assessed by a segmental bioelectrical impedancemeter before and after venous recanalization'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['iliac vein', 'inferior vena cava', 'exercice tolerance', 'cardio-pulmonary exercice testing', 'muscle physiological testing'], 'conditions': ['Post Thrombotic Syndrome', 'Venous Thromboses', 'Claudication, Intermittent']}, 'descriptionModule': {'briefSummary': 'Post-thrombotic syndrome (PTS) is the most frequently observed chronic complication of deep vein thrombosis (DVT), with an estimated cumulative incidence of 20-50%. Endovascular venous recanalization with angioplasty and stenting of obstructive lesions is the recommended treatment option to reduce or correct the symptoms of DVT. However, its impact on the physical capacity and breathlessness of patients has not been fully demonstrated. The heterogeneous evidences of clinical improvement is probably related to the presence or absence of collateral veins developed in these patients with proximal venous obstruction (iliac or iliofemoral with or without inferior vena cava involvement), which ensure the cardiac venous return. The aim of this study is to compare changes in maximal oxygen uptake after endovascular venous recanalization in DVT patients and to evaluate the hemodynamic, respiratory and muscular improvement induced by the restoration of venous flow in the occluded segments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient eligible for endovascular treatment for post-thrombotic syndrome in a chronic context (6 months after the occurrence of thrombosis, without time limit), after validation of the indication during a monthly medical-radiological PCR (St Eloi vascular medicine team and vascular radiologist performing the endovascular treatment)\n* Age \\>= 18 years\n\nExclusion Criteria:\n\n* Contraindication to the performance of a maximal effort test on a cyclo-ergometer\n* Refusal of consent after information\n* Adult protected by law (guardianship, curatorship)\n* Pregnant or breastfeeding woman\n* Patient not affiliated to a social security system or not benefiting from such a system'}, 'identificationModule': {'nctId': 'NCT05794932', 'acronym': 'ETERecaVSPT', 'briefTitle': 'Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome: ETERecaVSPT', 'orgStudyIdInfo': {'id': 'RECHMPL22_0560'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stress test', 'description': 'All patients will undergo a stress test before and after venous recanalization.', 'interventionNames': ['Diagnostic Test: Stress test']}], 'interventions': [{'name': 'Stress test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnostic Test:\n\n* Maximum effort test (CPET) on a cycloergometer\n* Leg muscle strength assessment\n* Leg muscle mass, composition and water compartments (segmental bioelectrical impedance)\n* Spirometry, arterial blood gaz, NO/CO transfer', 'armGroupLabels': ['Stress test']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montpellier', 'country': 'France', 'facility': 'Hopital Arnaud de Villeneuve - CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}