Aneurysmorrhaphy of Vascular Access for Haemodialysis (AVAH)
Primary Purpose
Patients With an Aneurysm of Native Vascular Access Indicated for Surgical Treatment
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun)
Sponsored by
About this trial
This is an interventional treatment trial for Patients With an Aneurysm of Native Vascular Access Indicated for Surgical Treatment
Eligibility Criteria
Inclusion Criteria:
- Signature of informed consent.
- A male or female subject aged 18 or older.
- A subject with a naive vascular access aneurysm indicated for surgical treatment.
Exclusion Criteria:
- Patients with pseudoaneurysm of prosthetic vascular access
- Patients with a vascular access infection
Sites / Locations
- Department of Surgery, Faculty Hospital Kralovske Vinohrady, 3rd Medical Faculty, Charles UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Aneurysmorrhaphy with external porous prosthesis (Provena©)
Aneurysmorrhaphy without external porous prosthesis
Arm Description
Outcomes
Primary Outcome Measures
Patency and aneurysms recurrence at 12 months after operation
Secondary Outcome Measures
Complications at 12 months
Full Information
NCT ID
NCT03262467
First Posted
August 23, 2017
Last Updated
July 30, 2022
Sponsor
Faculty Hospital Kralovske Vinohrady
1. Study Identification
Unique Protocol Identification Number
NCT03262467
Brief Title
Aneurysmorrhaphy of Vascular Access for Haemodialysis
Acronym
AVAH
Official Title
Aneurysmorrhaphy of Vascular Access for Haemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty Hospital Kralovske Vinohrady
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Several 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.
In 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.
AAVF 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With an Aneurysm of Native Vascular Access Indicated for Surgical Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aneurysmorrhaphy with external porous prosthesis (Provena©)
Arm Type
Active Comparator
Arm Title
Aneurysmorrhaphy without external porous prosthesis
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun)
Intervention 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.
Primary Outcome Measure Information:
Title
Patency and aneurysms recurrence at 12 months after operation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Complications at 12 months
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signature of informed consent.
A male or female subject aged 18 or older.
A subject with a naive vascular access aneurysm indicated for surgical treatment.
Exclusion Criteria:
Patients with pseudoaneurysm of prosthetic vascular access
Patients with a vascular access infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Baláž, MD, PhD.
Phone
+420776882216
Email
balaz.peter.pb@gmail.com
Facility Information:
Facility Name
Department of Surgery, Faculty Hospital Kralovske Vinohrady, 3rd Medical Faculty, Charles University
City
Prague
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Balaz, MD, PhD
Phone
+420 776 882 216
Email
balaz.peter.pb@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
14603208
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.
Results Reference
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PubMed Identifier
16797276
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.
Results Reference
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PubMed Identifier
19000589
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.
Results Reference
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PubMed Identifier
18609522
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.
Results Reference
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PubMed Identifier
20202869
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.
Results Reference
background
PubMed Identifier
24530180
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.
Results Reference
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PubMed Identifier
27225601
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.
Results Reference
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PubMed Identifier
3528676
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.
Results Reference
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PubMed Identifier
10764272
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.
Results Reference
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Aneurysmorrhaphy of Vascular Access for Haemodialysis
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