Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2026-01-17 @ 10:11 PM
Study NCT ID:
NCT06437561
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2024-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Report of Ten Cases of Venous Aneurysm in Extremities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-31', 'studyFirstSubmitDate': '2024-05-25', 'studyFirstSubmitQcDate': '2024-05-25', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical presentation of extremity venous aneurysms', 'timeFrame': '6 years', 'description': 'different clinical presentations of extremity venous aneurysms and their prevalence'}, {'measure': 'age distribution of extremity venous aneurysms', 'timeFrame': '6 years', 'description': 'prevalence of extremity venous aneurysms in different ages'}, {'measure': 'location distribution of extremity venous aneurysms', 'timeFrame': '6 years', 'description': 'prevalence of extremity venous aneurysms in upper vs. lower limbs as well as left side vs. right side'}, {'measure': 'sex distribution of extremity venous aneurysms', 'timeFrame': '6 years', 'description': 'prevalence of extremity venous aneurysms in both sexes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aneurysm', 'venous malformation', 'vascular surgery'], 'conditions': ['Venous Aneurysm Nos', 'Arteriovenous Malformations', 'Vascular Diseases']}, 'descriptionModule': {'briefSummary': 'Venous aneurysms are not common in general, but because of the inherent risk of thrombosis in aneurysms, their timely diagnosis and treatment are recommended in most of the current sources. Ten cases of venous aneurysms were diagnosed and managed in our vascular surgery department from October 2018 to January 2024. Patient information was extracted from their files retrospectively.', 'detailedDescription': 'A vascular aneurysm is defined as the focal dilatation of a vessel. Aneurysm is classically used for arterial dilatations, although dilatations can occur in any part of the vascular system including veins. Venous aneurysms are not common in general, but with the increase in the use of duplex ultrasound, the number of cases diagnosed with venous aneurysms has recently increased. Venous aneurysms are more common in the lower limbs, and in the lower limbs, the involvement of the deep venous system is much more than the superficial venous system. According to reports, 77% of venous aneurysms are present in the lower limbs, of which 57% are in the deep venous system and 1.5% in the superficial venous system.\n\nConsidering their rarity, venous aneurysms may cause diagnostic challenges in some cases.\n\nThe importance of these aneurysms, especially in the lower limbs, which inherently have relative stasis due to the opposite flow direction of gravity, is that by creating venous stasis and whirlwind blood flow inside the aneurysm, they increase the susceptibility to clotting. Also, due to dysfunction of the pigeon nest valves, they cause chronic venous insufficiency. Although clot formation and subsequent pulmonary embolism are more common in deep venous aneurysms, cases of pulmonary embolism secondary to superficial venous aneurysms of the lower limbs have also been reported.\n\nComplications caused by chronic venous insufficiency are more common in aneurysms that occur at the main junctions of superficial and deep veins, including saphenous femoral and saphenous popliteal junctions.\n\nConsidering the possible complications mentioned about venous aneurysms, these aneurysms need treatment, regardless of their location, and although in the superficial system, surgical resection is the most commonly recommended method, other surgical methods such as aneurysmectomy and primary repair, resection, and graft interposition, and also endovascular methods have been used. Of course, in case of insufficiency in the venous system, specific treatment of the cause of insufficiency (such as stripping of the large saphenous vein) is necessary in addition to the treatment of the aneurysm.\n\nRegarding the follow-up after the treatment of aneurysms of the superficial system, most articles have recommended short-term treatment with anticoagulants and control of the superficial and deep systems through color doppler.\n\nIn this case series, we present 10 cases of venous aneurysms and discuss their presentation, diagnosis, and management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients with extremity venous aneurysm since 2018 to 2024', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n• Clinical diagnosis of venous aneurysm\n\nExclusion Criteria:\n\n• Patient's non-consent"}, 'identificationModule': {'nctId': 'NCT06437561', 'briefTitle': 'Report of Ten Cases of Venous Aneurysm in Extremities', 'organization': {'class': 'OTHER', 'fullName': 'Golestan University of Medical sciences'}, 'officialTitle': 'Venous Aneurysm: a Case Series and Review of Literature', 'orgStudyIdInfo': {'id': '114099'}}, 'contactsLocationsModule': {'locations': [{'zip': '4917956808', 'city': 'Gorgan', 'state': 'Golestan Province', 'country': 'Iran', 'facility': 'Pezhman Kharazm, MD', 'geoPoint': {'lat': 36.8427, 'lon': 54.44391}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Golestan University of Medical sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vascular Surgeon', 'investigatorFullName': 'Pezhman Kharazm, MD', 'investigatorAffiliation': 'Golestan University of Medical sciences'}}}}