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CompletedNCT03262467AVAHUpdated Feb 28, 2024

Aneurysmorrhaphy of Vascular Access for Haemodialysis

An interventional study of Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun) in Patients With an Aneurysm of Native Vascular Access Indicated for Surgical Treatment, sponsored by Faculty Hospital Kralovske Vinohrady. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Faculty Hospital Kralovske Vinohrady · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
115
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Patients With an Aneurysm of Native Vascular Access Indicated for Surgical Treatment

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Signature of informed consent.
  2. A male or female subject aged 18 or older.
  3. A subject with a naive vascular access aneurysm indicated for surgical treatment.

Exclusion criteria

Exclusion Criteria:

  1. Patients with pseudoaneurysm of prosthetic vascular access
  2. Patients with a vascular access infection
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
115 participants (actual)

Study arms

  • Active comparator
    Aneurysmorrhaphy with external porous prosthesis (Provena©)

    Procedure: Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun)

  • Placebo comparator
    Aneurysmorrhaphy without external porous prosthesis

    Procedure: Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun)

Interventions

  • ProcedureAneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun)

    In patients with aneurysm of native vascular access indicated for surgical treatment, aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun) wil be performed.

05

What researchers measure

Primary outcomes

  1. Patency and aneurysms recurrence at 12 months after operation

    Time frame: 12 months

Secondary outcomes

  1. Complications at 12 months

    Time frame: 12 months

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Study locations

1 site
  • Department of Surgery, Faculty Hospital Kralovske Vinohrady, 3rd Medical Faculty, Charles University
    Prague, Czechia
07

References and documents

Publications

  • 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. PubMed 14603208 ↗
  • 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. PubMed 16797276 ↗
  • 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. PubMed 19000589 ↗
  • 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. PubMed 18609522 ↗
  • 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. PubMed 20202869 ↗
  • 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. PubMed 24530180 ↗
  • 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. PubMed 27225601 ↗
  • 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. PubMed 3528676 ↗
  • 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. PubMed 10764272 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03262467
Lead sponsor
Faculty Hospital Kralovske Vinohrady
Responsible party
Peter Balaz (Principal Investigator, Faculty Hospital Kralovske Vinohrady) — Principal investigator
First posted
Aug 25, 2017
Start date
Jan 31, 2018
Primary completion
Jul 1, 2023
Completion
Sep 1, 2023
Last update
Feb 28, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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