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Aneurysmorrhaphy of Vascular Access for Haemodialysis

Aneurysmorrhaphy of Vascular Access for Haemodialysis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03262467
Acronym
AVAH
Enrollment
115
Registered
2017-08-25
Start date
2018-01-31
Completion date
2023-09-01
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Sponsors

Faculty Hospital Kralovske Vinohrady
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frame
Patency and aneurysms recurrence at 12 months after operation12 months

Secondary

MeasureTime frame
Complications at 12 months12 months

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026