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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

Must not have

Age below 18 years

Participants eligible for low forearm AVF (radio-cephalic)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older and scheduled for an arteriovenous fistula procedure.

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My ultrasound before surgery showed I can have a special type of vein access for dialysis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I am eligible for a specific type of arm vein access for dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Surgical Portacaval Shunt (procedure)

Secondary study objectives

Clinical fistula maturity

Fistula survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met