Endovascular vs Surgical Arteriovenous Fistula Outcomes

Dialysis Fistula Creation Clinical Trial

— ESAVFO  

Official title:

Endovascular vs Surgical Arteriovenous Fistula Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04404985
• Other study ID #: F0002
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: January 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but many of them fail to mature. There are two techniques of creating AVFs either the traditional way with surgery( Surgical AVFs) or novel per-cutaneous technique Endo- AVFs.

Investigators will pilot an randomized clinical trial of endo-AVFs and surgical AVFs at University of Alabama at Birmingham to determine the feasibility of patient recruitment, randomization, and retention. This pilot study will set the stage for a full-scale randomized clinical trial in future.

Description:

Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but many of them fail to mature. Despite concerted efforts to improve surgical AVF outcomes during the past 20 years, many new AVFs fail to mature, even after interventions to salvage them (assisted maturation). Postoperative ultrasounds of immature AVFs frequently demonstrate decreased flow with narrowing at the anastomosis . Surgically created AVFs typically have a 90o angle at the anastomosis, yet computational fluid dynamics suggest that an anastomotic angle <30o improves the flow hemodynamics. Therefore, there has been great interest in novel AVF technologies to limit vascular injury and improve flow dynamics and maturation rates. The new technology evaluated herein (endovascular AVF (endo-AVF) has the potential to achieve these goals and reduce the cost of vascular access care.

Endo-AVF, a novel per-cutaneous technique of AVF creation, was approved by the FDA in 2018, and has been used in U.S. hemodialysis patients . In contrast to the surgical technique (the current standard), this non-surgical approach (1) minimizes vascular injury at the time of AVF creation and (2) creates a channel between the artery and vein with an angle approaching 0o. These two features provide a scientific rationale for superior maturation compared with that of surgical AVF Investigators will perform a single-center, prospective pilot randomized clinical trial. Investigators will recruit 80 patients who have advanced chronic kidney disease or on hemodialysis with a catheter ,who there pre- operative Ultrasound showed they are eligible to surgical or endo-vascular AVF. Participants will be randomized to one of two groups: an surgical AVF intervention group that will undergo a routine surgical fistula creation, or an endo-vascular AVF intervention group will undergo per-cutaneous fistula creation . Participants will be followed for 2 years.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: September 30, 2025
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Age below 18 years

• participants eligible for low forearm AVF ( radio-cephalic)

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Dialysis Fistula Creation
• Endo-vascular AVFs
• Fistula

Intervention

Procedure:
• Surgical AVF
Surgical fistula creation is standard surgical procedures, where a small cut through the skin is made to create a channel directly between a vein and artery . The study procedures are standard clinical practice, and not considered an experimental procedure.
• Endo-vascular AVF
Endovascular fistula creation is a minimally invasive procedure used to create a canal between close artery and vein at the forearm. A magnet attached to a catheter is passed over a guidewire into the artery while another magnet passed over the guidewire into the vein. The two magnets are aligned close to each other, then the radiofrequency electrode is released from the venous catheter and energized for 2 seconds, creating a channel between the vein and the artery.

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological fistula maturity	Assess by ultrasound . To assess blood flow within the fistula.	0-6 weeks
Primary	Physiological fistula maturity	Assess by ultrasound . To assess diameter of the fistula	0-6 weeks
Secondary	Clinical fistula maturity	Assess by ultrasound. Able to use the fistula for dialysis	6 weeks-6 months
Secondary	Fistula survival	Assess by ultrasound. Continue to able to use fistula for dialysis	0-2 years