Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-03-01 @ 9:42 AM
Study NCT ID:
NCT03262467
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2017-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aneurysmorrhaphy of Vascular Access for Haemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-24', 'studyFirstSubmitDate': '2017-08-23', 'studyFirstSubmitQcDate': '2017-08-24', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patency and aneurysms recurrence at 12 months after operation', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Complications at 12 months', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients With an Aneurysm of Native Vascular Access Indicated for Surgical Treatment']}, 'referencesModule': {'references': [{'pmid': '14603208', 'type': 'BACKGROUND', 'citation': 'Huber TS, Carter JW, Carter RL, Seeger JM. Patency of autogenous and polytetrafluoroethylene upper extremity arteriovenous hemodialysis accesses: a systematic review. J Vasc Surg. 2003 Nov;38(5):1005-11. doi: 10.1016/s0741-5214(03)00426-9.'}, {'pmid': '16797276', 'type': 'BACKGROUND', 'citation': 'Salahi H, Fazelzadeh A, Mehdizadeh A, Razmkon A, Malek-Hosseini SA. Complications of arteriovenous fistula in dialysis patients. Transplant Proc. 2006 Jun;38(5):1261-4. doi: 10.1016/j.transproceed.2006.02.066.'}, {'pmid': '19000589', 'type': 'BACKGROUND', 'citation': "Sidawy AN, Spergel LM, Besarab A, Allon M, Jennings WC, Padberg FT Jr, Murad MH, Montori VM, O'Hare AM, Calligaro KD, Macsata RA, Lumsden AB, Ascher E; Society for Vascular Surgery. The Society for Vascular Surgery: clinical practice guidelines for the surgical placement and maintenance of arteriovenous hemodialysis access. J Vasc Surg. 2008 Nov;48(5 Suppl):2S-25S. doi: 10.1016/j.jvs.2008.08.042."}, {'pmid': '18609522', 'type': 'BACKGROUND', 'citation': 'Balaz P, Rokosny S, Klein D, Adamec M. Aneurysmorrhaphy is an easy technique for arteriovenous fistula salvage. J Vasc Access. 2008 Apr-Jun;9(2):81-4.'}, {'pmid': '20202869', 'type': 'BACKGROUND', 'citation': 'Berard X, Brizzi V, Mayeux S, Sassoust G, Biscay D, Ducasse E, Bordenave L, Corpataux JM, Midy D. Salvage treatment for venous aneurysm complicating vascular access arteriovenous fistula: use of an exoprosthesis to reinforce the vein after aneurysmorrhaphy. Eur J Vasc Endovasc Surg. 2010 Jul;40(1):100-6. doi: 10.1016/j.ejvs.2010.01.021. Epub 2010 Mar 3.'}, {'pmid': '24530180', 'type': 'BACKGROUND', 'citation': 'Rokosny S, Balaz P, Wohlfahrt P, Palous D, Janousek L. Reinforced aneurysmorrhaphy for true aneurysmal haemodialysis vascular access. Eur J Vasc Endovasc Surg. 2014 Apr;47(4):444-50. doi: 10.1016/j.ejvs.2014.01.010. Epub 2014 Jan 21.'}, {'pmid': '27225601', 'type': 'BACKGROUND', 'citation': 'Wohlfahrt P, Rokosny S, Melenovsky V, Borlaug BA, Pecenkova V, Balaz P. Cardiac remodeling after reduction of high-flow arteriovenous fistulas in end-stage renal disease. Hypertens Res. 2016 Sep;39(9):654-9. doi: 10.1038/hr.2016.50. Epub 2016 May 26.'}, {'pmid': '3528676', 'type': 'BACKGROUND', 'citation': 'Barra JA, Volant A, Leroy JP, Braesco J, Airiau J, Boschat J, Blanc JJ, Penther P. Constrictive perivenous mesh prosthesis for preservation of vein integrity. Experimental results and application for coronary bypass grafting. J Thorac Cardiovasc Surg. 1986 Sep;92(3 Pt 1):330-6.'}, {'pmid': '10764272', 'type': 'BACKGROUND', 'citation': 'Meguro T, Nakashima H, Kawada S, Tokunaga K, Ohmoto T. Effect of external stenting and systemic hypertension on intimal hyperplasia in rat vein grafts. Neurosurgery. 2000 Apr;46(4):963-9; discussion 969-70. doi: 10.1097/00006123-200004000-00036.'}]}, 'descriptionModule': {'briefSummary': 'In patients with chronic renal failure, a well-functioning vascular access is essential for hemodialysis treatment. Native arteriovenous fistula (AVF) is the first-choice of vascular access, due to a lower incidence of complications and better long-term patency as compared to prosthetic arteriovenous fistula. With the incidence ranging between 6-60%, AVF aneurysm (AAVF) is a common complication of native AVF. According to Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines, asymptomatic aneurysms are indicated for conservative treatment, but precise recommendations when and how to intervene in available guidelines are missing.\n\nSeveral surgical (remodeling, resection and substitution, ligation) and endovascular techniques have been described in the AAVF treatment, but there is currently no prospective randomized study comparing these techniques.\n\nIn 2008, our team published the first experience with a new surgical method of AAVF treatment - aneurysmorrhaphy with external porous prosthesis (Provena©, BBraun). This therapy was validated in several studies and has shown a good long-term patency and a minimal incidence of complications.\n\nAAVF aneurysmorrhaphy can be performed with or without an external porous prosthesis (Provena©, BBraun). The use of external prostheses reduces venous wall shear stress, turbulent flow, endothelial damage, and thrombus formation, which should improve vascular patency and reduce the risk of AVF re-aneurysm. So far, there is no prospective randomized study comparing the effect of external porous prosthesis on AVF patency and the incidence of postoperative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signature of informed consent.\n2. A male or female subject aged 18 or older.\n3. A subject with a naive vascular access aneurysm indicated for surgical treatment.\n\nExclusion Criteria:\n\n1. Patients with pseudoaneurysm of prosthetic vascular access\n2. Patients with a vascular access infection'}, 'identificationModule': {'nctId': 'NCT03262467', 'acronym': 'AVAH', 'briefTitle': 'Aneurysmorrhaphy of Vascular Access for Haemodialysis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Faculty Hospital Kralovske Vinohrady'}, 'officialTitle': 'Aneurysmorrhaphy of Vascular Access for Haemodialysis', 'orgStudyIdInfo': {'id': 'AVAH_V1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aneurysmorrhaphy with external porous prosthesis (Provena©)', 'interventionNames': ['Procedure: Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Aneurysmorrhaphy without external porous prosthesis', 'interventionNames': ['Procedure: Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun)']}], 'interventions': [{'name': 'Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun)', 'type': 'PROCEDURE', 'description': 'In patients with aneurysm of native vascular access indicated for surgical treatment, aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun) wil be performed.', 'armGroupLabels': ['Aneurysmorrhaphy with external porous prosthesis (Provena©)', 'Aneurysmorrhaphy without external porous prosthesis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'country': 'Czechia', 'facility': 'Department of Surgery, Faculty Hospital Kralovske Vinohrady, 3rd Medical Faculty, Charles University', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty Hospital Kralovske Vinohrady', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Peter Balaz', 'investigatorAffiliation': 'Faculty Hospital Kralovske Vinohrady'}}}}