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Not yet recruitingNCT06855914Updated Mar 4, 2025

Outcomes of Surgical Management of Aneurysmal Arteriovenous Fistula in Hemodialysis Patients

An interventional study of surgerical repair in Arteriovenous Fistula Patency, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-04.

Sponsored by Assiut University · Not applicable, Interventional, and Other

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Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the success rate and patency after surgical management of Arteriovenous fistulas aneurysms

Read the detailed description

End-stage renal failure is a disease that can affect all organs. The increasing prevalence of affluent-society diseases such as obesity, diabetes, hypertension, or atherosclerosis means that the number of patients diagnosed with end-stage renal disease is systematically growing . Worldwide, the number of patients receiving hemodialysis is estimated at more than 1.4 million, with the annual incident rate growing to 8%, prevalence of ESRD in Egypt raised to 483 patients per million. A well-functioning vascular access is a mainstay to perform an efficient haemodialysis . AVF, described by Brescia and Cimino, remains the first choice for chronic Haemodialysis . It is the best access for longevity and has the lowest association with morbidity and mortality, and for this reason AVF use is strongly recommended by guidelines from different countries . The most common complications of fistulae for HD are lymphedema, infection, aneurysm, stenosis, congestive heart failure, steal syndrome, ischemic neuropathy and thrombosis. It is important to gain information about early clinical symptoms of AVF dysfunction in order to prevent and adequately treat potential complications . Arteriovenous fistula aneurysms are defined by an expansion of the intimal, medial and adventitial layers of the vessel wall to a diameter of more than 18 mm. Aneurysmal degeneration of the venous component of surgically created arteriovenous fistulae (AVFs) is a common clinical finding. prevalence rates ranging widely between 6% and 51% depending on criteria. Although arteriovenous fistula aneurysms (AVFAs) can be prone to thrombosis and can cause cosmetic dissatisfaction, the most catastrophic complication is life-threatening haemorrhage . The decision for surgical intervention relies on the risk of perforation, ulceration, bleeding, and size of aneurysm which leaves a limited space for puncture. The surgical modalities include excision of the aneurysm and primary repair, excision of the aneurysm and interposition graft , repair by end-to-end anastomosis, ligation .

02

Conditions studied

  • Arteriovenous Fistula Patency

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03

In context

Arteriovenous Fistula

248 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.

This study's planned enrollment of 46 is below the median of 64 across 166 interventional studies indexed under Arteriovenous Fistula.

Browse Arteriovenous Fistula studies →

Lead sponsor

Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients with pseudo-aneurysms over AVF
  • skin Changes ( Ulceration - Inflammation -Necrosis)
  • Huge Enlargement with lack of potential site of Cannulation
  • Impending thrombosis of the fistula
  • Risk of infection and impending rupture
  • Significant Cosmetic concerns causing distress to the patient

Exclusion criteria

Exclusion Criteria:

  • Bad general condition, patient with severe comorbidities
  • Thrombosed AV fistula
  • Age \< 18 years
  • Anastomotic aneurysms
  • Venous Hypertension over AVF
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    surgical repair

    surgical repair of AVF

    Procedure: surgerical repair

Interventions

  • Proceduresurgerical repair

    surgical repair of AVF aneurysm

06

What researchers measure

Primary outcomes

  1. evaluate patency after surgical repair

    evaluate patency after surgical repair of aneurysmal arteriovenous fistula

    Time frame: baseline

  2. evaluate success rate after repair

    success rate of surgical repair of aneurysm and can use fistula for further dialysis or not

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Stolic R. Most important chronic complications of arteriovenous fistulas for hemodialysis. Med Princ Pract. 2013;22(3):220-8. doi: 10.1159/000343669. Epub 2012 Nov 2. PubMed 23128647 ↗
  • Santoro D, Benedetto F, Mondello P, Pipito N, Barilla D, Spinelli F, Ricciardi CA, Cernaro V, Buemi M. Vascular access for hemodialysis: current perspectives. Int J Nephrol Renovasc Dis. 2014 Jul 8;7:281-94. doi: 10.2147/IJNRD.S46643. eCollection 2014. PubMed 25045278 ↗
  • 2. Abdel-Fattah El-Ballat M, Ahmed El-Sayed M, Kamel Abdel-Raouf Emam H. Epidemiology of End Stage Renal Disease Patients on Regular Hemodialysis in El-Beheira Governorate, Egypt. Vol. 76, The Egyptian Journal of Hospital Medicine. 2019.
  • Plonski A, Plonski AF, Glowinski J. Surgical Management, Prevention and Outcomes for Aneurysms of Arteriovenous Dialysis Fistulas: A Case Series Study and Review. Int J Environ Res Public Health. 2023 Jun 29;20(13):6256. doi: 10.3390/ijerph20136256. PubMed 37444103 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2025; primary completion for Sep 2026, 19 months later.

Of 58 non-industry interventional studies with no phase under Arteriovenous Fistula, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 43. This study's planned 19 months is close to that.

Counting every sponsor, half of 84 studies reached it within 22 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2025
First posted
Mar 4, 2025
StartEst.
Feb 25, 2025
Primary completionEst.
Sep 2026
CompletionEst.
Oct 2026
Last update
Mar 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06855914
Lead sponsor
Assiut University
Responsible party
abanoub saad anis (Principal investigator, Assiut University) — Principal investigator
First posted
Mar 4, 2025
Start date
Feb 25, 2025 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Mar 4, 2025

Study contacts

abanoub saad anis, master
Contact
abanoobsaad1000@gmail.com
+201288140668
mahmoud ismael ahmed, prof doctor
Contact
Mahmoud.saleh1@med.aun.edu.eg
+201006228283

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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