Clinical trial NCT04404985: Endovascular vs Surgical Arteriovenous Fistula Outcomes
Official title: Endovascular vs Surgical Arteriovenous Fistula Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dialysis Fistula Creation
Endo-vascular AVFs
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Physiological fistula maturity
timeFrame: 0-6 weeks
measure: Physiological fistula maturity
timeFrame: 0-6 weeks
Secondary outcomes:
measure: Clinical fistula maturity
timeFrame: 6 weeks-6 months
measure: Fistula survival
timeFrame: 0-2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
References: