Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT07012551
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endovascular Modalites for Contralateral Common Iliac Artery in Patients With Symptomatic Unilateral Common Iliac Artery Occlusive Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-01', 'studyFirstSubmitDate': '2025-06-01', 'studyFirstSubmitQcDate': '2025-06-01', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary patency of both common iliac arteries', 'timeFrame': '2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iliac Artery Disease']}, 'referencesModule': {'references': [{'pmid': '20185041', 'type': 'BACKGROUND', 'citation': 'Aboyans V, Desormais I, Lacroix P, Salazar J, Criqui MH, Laskar M. The general prognosis of patients with peripheral arterial disease differs according to the disease localization. J Am Coll Cardiol. 2010 Mar 2;55(9):898-903. doi: 10.1016/j.jacc.2009.09.055.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety, efficacy, and outcomes of endovascular strategies for protection of the contralateral CIA in patients with symptomatic unilateral CIA occlusive disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients attending the Vascular Surgery Clinics in Assiut University Hospitals complaining of unilateral CIA ostial occlusive disease, Rutherford category 3, 4and 5 will be recruited to participate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic patients (Rutherford category 3- 5) due to Unilateral common iliac artery occlusive disease.\n\nwith or without combined iliac or femoropopliteal or infrapopliteal lesions.\n\nAsymptomatic Contralateral limb.\n\nPatent at least one run-off vessel\n\nExclusion Criteria:\n\n* Distal aorta lesion\n\ncontralateral CIA occlusion\n\nPrevious endovascular or surgical procedures for the same lesion\n\nHypersensitivity to contrast material\n\nPresence of aortic or iliac aneurysms\n\nPatients with unsalvageable limb\n\nNon atherosclerotic lesions'}, 'identificationModule': {'nctId': 'NCT07012551', 'briefTitle': 'Endovascular Modalites for Contralateral Common Iliac Artery in Patients With Symptomatic Unilateral Common Iliac Artery Occlusive Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Endovascular Modalites for Contralateral Common Iliac Artery in Patients With Symptomatic Unilateral Common Iliac Artery Occlusive Disease', 'orgStudyIdInfo': {'id': 'Common iliac artery stenting'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Common iliac artery stenting', 'type': 'PROCEDURE', 'description': 'Stenting of common iliac artery by balloon mounted stent'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'abdelrahman eltokhey', 'role': 'CONTACT', 'email': 'abdelrahmaneltokhey11@gmail.com', 'phone': '01003830585'}, {'name': 'mahmoud ismail', 'role': 'CONTACT', 'email': 'mahmoudismail79@yahoo.com', 'phone': '0106228283'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Abdelrahman Ahmed Shawki Roshdi', 'investigatorAffiliation': 'Assiut University'}}}}