Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT03405233
Status:
UNKNOWN
Last Update Posted:
2018-02-14
First Post:
2018-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients (Extended Poly Tetra Fluoro Ethylene)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'the patients do not know which group will they belong the duplex operator will not know the details of operative data'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-12', 'studyFirstSubmitDate': '2018-01-12', 'studyFirstSubmitQcDate': '2018-01-18', 'lastUpdatePostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary patency', 'timeFrame': '2 years for each patient after the operation', 'description': 'comparing primary patency between the double cuffed, single cuffed and non cuffed ePTFE graft primary patency means how long will the graft be patent after the first intervention'}], 'secondaryOutcomes': [{'measure': 'secondary patency', 'timeFrame': '2 years after restoration of patency', 'description': 'comparing secondary patency between the double cuffed, single cuffed and non cuffed ePTFE graft secondary patency means how long will the graft be patent after thormobectomy to a thrombosed graft'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ESRD', 'ePTFE', 'neointemal hyperplasia'], 'conditions': ['End Stage Renal Disease']}, 'referencesModule': {'references': [{'pmid': '16754802', 'type': 'BACKGROUND', 'citation': 'Cheng C, Tempel D, van Haperen R, van der Baan A, Grosveld F, Daemen MJ, Krams R, de Crom R. Atherosclerotic lesion size and vulnerability are determined by patterns of fluid shear stress. Circulation. 2006 Jun 13;113(23):2744-53. doi: 10.1161/CIRCULATIONAHA.105.590018. Epub 2006 Jun 5.'}, {'pmid': '26787576', 'type': 'BACKGROUND', 'citation': 'Ghonemy TA, Farag SE, Soliman SA, El-okely A, El-hendy Y. Epidemiology and risk factors of chronic kidney disease in the El-Sharkia Governorate, Egypt. Saudi J Kidney Dis Transpl. 2016 Jan;27(1):111-7. doi: 10.4103/1319-2442.174137.'}, {'pmid': '23371958', 'type': 'BACKGROUND', 'citation': 'Ong S, Barker-Finkel J, Allon M. Long-term outcomes of arteriovenous thigh grafts in hemodialysis patients: a comparison with tunneled dialysis catheters. Clin J Am Soc Nephrol. 2013 May;8(5):804-9. doi: 10.2215/CJN.09240912. Epub 2013 Jan 31.'}, {'pmid': '18343971', 'type': 'BACKGROUND', 'citation': 'Tsoulfas G, Hertl M, Ko DS, Elias N, Delmonico FL, Romano L, Fernandes I, Schoenfeld D, Kawai T. Long-term outcome of a cuffed expanded PTFE graft for hemodialysis vascular access. World J Surg. 2008 Aug;32(8):1827-31. doi: 10.1007/s00268-008-9514-z.'}]}, 'descriptionModule': {'briefSummary': 'this randomized controlled trial will compare the double vein cuffed synthetic arteriovenous graft to the single vein cuffed synthetic and the non cuffed synthetic as regard to long-term patency of each modality', 'detailedDescription': 'End-stage renal disease (ESRD) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years.End-stage renal disease (ESRD) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years. Haemodialysis (HD) is a lifeline therapy for patients with ESRD. A proportion of hemodialysis patients exhaust all options for permanent vascular access (fistula or graft) in both upper extremities.ePTFE grafts are easily subjected to graft outflow tract intimal hyperplasia, which may lead to graft outlet stenosis and graft thrombosis after a certain period of usage. The commonest cause of PTFE graft failure is intimal hyperplasia (IH) at the venous anastomoses. our study aims to evaluate the influence of double cuffed ePTFE grafts with autologous vein cuffs on the long-term patency of dialysis access, and compare the clinical patency and the complications occurring with the usage of the double cuffed graft to that with standard non cuffed grafts in chronic renal hemodialysis therapy.\n\nthis randomized controlled trial will compare the double vein cuffed synthetic arteriovenous graft to the single vein cuffed synthetic and the non cuffed synthetic as regard to long term patency of each modality'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with end stage renal diseases and GFR less than 30\n2. By clinical examination in ability to palpate distal or proximal upper limb veins 3. By duplex examination the diameter of cephalic or basilic veins are less than 3 mm or reported to be incompressible 4. Patients with previous history of failed attempts of autogenous vein creation 5. Patients with border line cephalic or basilica vein (3mm) and on intraoperative the vein diameter appears to be unsuitable (less than 3 mm).\n\nExclusion Criteria:\n\n1. All patients with palpable suitable forearm or arm veins\n2. Patients with baseline blood pressure less than 110/70\n3. Brachial artery of diameter less than 4 mm\n4. Patients with ligated brachial artery\n5. Patients with history of central vein stenosis\n6. Patients with immunodeficiency states'}, 'identificationModule': {'nctId': 'NCT03405233', 'acronym': 'ePTFE', 'briefTitle': 'Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients (Extended Poly Tetra Fluoro Ethylene)', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'R.18.01.6.R1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Double vein cuff PTFE graft both at the inflow and outflow ends', 'interventionNames': ['Procedure: Double vein cuffed ePTFE graft both at the inflow and outflow ends']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Single vein cuffed PTFE graft at the outflow end', 'interventionNames': ['Procedure: single vein cuffed eTFE graft both at the inflow and outflow ends']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'PTFE graft without vein cuff will be used', 'interventionNames': ['Procedure: ePTFE graft without any cuff']}], 'interventions': [{'name': 'Double vein cuffed ePTFE graft both at the inflow and outflow ends', 'type': 'PROCEDURE', 'description': 'Vein cuff is obtained from a segment of one of the arm veins (cephalic or basilica) after incising it longitudinally and wrapped around both ends of PTFE Graft', 'armGroupLabels': ['Group A']}, {'name': 'single vein cuffed eTFE graft both at the inflow and outflow ends', 'type': 'PROCEDURE', 'description': 'Vein cuff is obtained from a segment of one of the arm veins (cephalic or basilica) after incising it longitudinally and wrapped around the venous end of PTFE Graft', 'armGroupLabels': ['Group B']}, {'name': 'ePTFE graft without any cuff', 'type': 'PROCEDURE', 'description': 'anastmosis between arterial and venous side usinf non cuffed ePTFE graft', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Delta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Abdelaziz Mohamed Hussien, Assistant professor', 'role': 'CONTACT', 'email': 'menhag@mans.edu.eg', 'phone': '01002421140', 'phoneExt': '+2'}, {'name': 'Amr Mohamed Elshafei, Assist lecturer', 'role': 'CONTACT', 'email': 'amrelshafie@mans.edu.eg', 'phone': '01211336635', 'phoneExt': '+2'}], 'facility': 'Mansoura faculty of medicine', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Hussein mohamed Abdelaziz, PHD', 'role': 'CONTACT', 'email': 'menhag@mans.edu.eg', 'phone': '+201002421140', 'phoneExt': '+2'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of vascular surgery', 'investigatorFullName': 'Amr Elshafie', 'investigatorAffiliation': 'Mansoura University'}}}}