NCT06855914

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Feb 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Feb 2025Oct 2026

First Submitted

Initial submission to the registry

February 2, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

February 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

1.5 years

First QC Date

February 2, 2025

Last Update Submit

February 27, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • evaluate patency after surgical repair

    evaluate patency after surgical repair of aneurysmal arteriovenous fistula

    baseline

  • evaluate success rate after repair

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

    baseline

Study Arms (1)

surgical repair

EXPERIMENTAL

surgical repair of AVF

Procedure: surgerical repair

Interventions

surgical repair of AVF aneurysm

surgical repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 23128647BACKGROUND
  • 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.

    PMID: 25045278BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 37444103BACKGROUND

Central Study Contacts

abanoub saad anis, master

CONTACT

mahmoud ismael ahmed, prof doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 2, 2025

First Posted

March 4, 2025

Study Start

February 25, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 4, 2025

Record last verified: 2025-02