Dialysis Fistula CreationESAVFONCT04404985
Endovascular vs Surgical Arteriovenous Fistula Outcomes
A study testing Surgical AVF and Endo-vascular AVF in people with Dialysis Fistula Creation and Endo-vascular AVFs, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis Fistula Creation, Endo-vascular AVFs
- What is being tested?
- Surgical AVF and Endo-vascular AVF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age below 18 years
- participants eligible for low forearm AVF ( radio-cephalic)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dialysis Fistula Creation, Endo-vascular AVFs
- Being tested
- Surgical AVF, Endo-vascular AVF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical AVFProcedure or surgery
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 AVFProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical AVFs | Active comparator | 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. Receives: Procedure: Surgical AVF |
| Endo-vascular AVF | Experimental | 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. Receives: Procedure: Endo-vascular AVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological fistula maturity
Assess by ultrasound . To assess blood flow within the fistula.
Measured: 0-6 weeks
Physiological fistula maturity
Assess by ultrasound . To assess diameter of the fistula
Measured: 0-6 weeks
Secondary outcomes (2)
Clinical fistula maturity
Assess by ultrasound. Able to use the fistula for dialysis
Measured: 6 weeks-6 months
Fistula survival
Assess by ultrasound. Continue to able to use fistula for dialysis
Measured: 0-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 May 2022
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis Fistula CreationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alian Al-Balas, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404985
- Sponsor's protocol ID
- F0002
- Acronym
- ESAVFO
- Status last verified
- Sep 2026
- First submitted
- 19 May 2020
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular vs Surgical Arteriovenous Fistula Outcomes
- ClinicalTrials.gov ID
- NCT04404985
- Acronym / sponsor ID
- ESAVFO / F0002
- Conditions
- Dialysis Fistula Creation, Endo-vascular AVFs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical AVFs | Active comparator | Procedure: Surgical AVFParticipants 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. |
| Endo-vascular AVF | Experimental | Procedure: Endo-vascular AVFParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Age below 18 years
- participants eligible for low forearm AVF ( radio-cephalic)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical AVFSurgical 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. | Procedure or surgery | Surgical AVFs |
| Endo-vascular AVFEndovascular 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. | Procedure or surgery | Endo-vascular AVF |
Primary outcome
Physiological fistula maturity
Time frame: 0-6 weeks
Assess by ultrasound . To assess blood flow within the fistula.
Physiological fistula maturity
Time frame: 0-6 weeks
Assess by ultrasound . To assess diameter of the fistula
2 secondary outcomes
Clinical fistula maturity
Time frame: 6 weeks-6 months
Fistula survival
Time frame: 0-2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical AVF and Endo-vascular AVF in people with Dialysis Fistula Creation and Endo-vascular AVFs, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological fistula maturity (time frame: 0-6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.