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Aneurysmorrhaphy of Vascular Access for Haemodialysis

NCT03262467 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2024-02-28

No results posted yet for this 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.

Conditions

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

Interventions

PROCEDURE

Aneurysmorrhaphy 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 & Collaborators

  • Faculty Hospital Kralovske Vinohrady

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2023-07-01
Completion
2023-09-01

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03262467 on ClinicalTrials.gov