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Vascular Access

Endovascular vs Surgical Techniques for Dialysis Fistula Creation (ESAVFO Trial)

N/A
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Study will include participants who are 18 years and older who are scheduled to have an AVF
Preoperative ultrasound showed feasibility to have an endo-vascular AVF vs surgical upper arm AVF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-2 years
Awards & highlights

ESAVFO Trial Summary

This trial will compare two techniques for creating an arteriovenous fistula for dialysis, the traditional surgical method and a new per-cutaneous technique, to see which is more effective.

Who is the study for?
This trial is for adults over 18 who need an arteriovenous fistula (AVF) for dialysis and can have either an endovascular AVF or a surgical upper arm AVF, as shown by preoperative ultrasound. It's not for those under 18 or patients eligible only for a low forearm AVF.Check my eligibility
What is being tested?
The study compares two methods of creating dialysis access: the traditional surgery (Surgical AVFs) and a newer, less invasive technique using catheters (Endo-AVFs). Participants will be randomly assigned to one of these techniques at the University of Alabama at Birmingham.See study design
What are the potential side effects?
Potential side effects may include complications like infection, clotting, bleeding from the site where the fistula was created, or issues with fistula maturation which could affect its usability for dialysis.

ESAVFO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older and scheduled for an arteriovenous fistula procedure.
Select...
My ultrasound before surgery showed I can have a special type of vein access for dialysis.

ESAVFO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Surgical Portacaval Shunt (procedure)
Secondary outcome measures
Clinical fistula maturity
Fistula survival

ESAVFO Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Endo-vascular AVFExperimental Treatment1 Intervention
Participants who initiated dialysis with a catheter or have advanced chronic kidney disease ,these patients who an endo-vascular AVF intervention group that will undergo a per-cutaneous AVF creation.
Group II: Surgical AVFsActive Control1 Intervention
Participants who initiated dialysis with a catheter or have advanced chronic kidney disease ,these patients who an Surgical AVF intervention group that will undergo a routine surgical AVF creation.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,565 Previous Clinical Trials
2,268,337 Total Patients Enrolled

Media Library

Endo-vascular AVF (Vascular Access) Clinical Trial Eligibility Overview. Trial Name: NCT04404985 — N/A
Endovascular Arteriovenous Fistulas Research Study Groups: Surgical AVFs, Endo-vascular AVF
Endovascular Arteriovenous Fistulas Clinical Trial 2023: Endo-vascular AVF Highlights & Side Effects. Trial Name: NCT04404985 — N/A
Endo-vascular AVF (Vascular Access) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04404985 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are expected to join this research trial?

"Indeed, clinicaltrials.gov indicates that this trial is actively recruiting participants. The research was first published on May 1st 2022 and has seen its most recent update on the 6th of the same month. 80 individuals will be recruited from a single site for this study."

Answered by AI

Is this investigation currently seeking participants?

"Data available on clinicaltrials.gov indicates that this trial is actively seeking participants, first being listed on May 1st of 2022 and last updated only a few days ago on the 6th."

Answered by AI
~7 spots leftby Mar 2025