End Stage Renal Disease on DialysisNCT05654103
Comparing Surgical and Endovascular Arteriovenous Fistula Creation
A study testing endoAVF and surgAVF in people with End Stage Renal Disease on Dialysis, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
Patients with end-stage kidney disease (ESKD) who use hemodialysis to filter their blood require vascular access for the dialysis machine; the most common type of vascular access is called an arteriovenous fistula (AVF). The AVF is a direct connect between an artery and vein. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- endoAVF and surgAVF
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Nov 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ESKD patients aged ≥ 18 who have chosen hemodialysis as their renal replacement option.
- Ability to give consent to participate in a research study.
- Upper arm vein diameter of ≥ 2.0 mm.
- Ellipsys specific inclusion criteria:
- Confirmed radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by preprocedural ultrasound and confirmed pre-procedurally.
- Confirmed radial artery and adjacent vein diameter of ≥ 2.0 mm at site where vein and artery connects.
- WavelinQ specific inclusion criteria:
- Target vein diameter ≥ 2.0 mm, target artery diameter ≥ 2.0 mm, and ≤ 2 mm between target artery and vein.
Who cannot join
- People under the age of 18.
- Inability to understand the consent process and/or give consent.
- Upper arm vein diameter less than 2.0 mm making them unsuitable to receive an surgAVF AND endoAVF.
- Patients who are deemed by the surgeon to be anatomic candidates for a forearm vascular access, and the surgeon and the patient determine that a forearm access is the optimal access for the patient, in order to preserve more proximal anatomic sites for future accesses.
- Currently incarcerated individuals.
- Currently pregnant or planning to get pregnant within the next 6 months.
- Individuals who choose peritoneal dialysis over hemodialysis and/or undergoing a kidney transplant within 6 months of randomization.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCLA Division of Vascular and Endovascular Surgery Clinic
Los Angeles, California, 90095
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15231
About this study
Official title: Randomized Controlled Trial Comparing endoAVF Versus surgAVF
Patients with end-stage kidney disease (ESKD) who use hemodialysis to filter their blood require vascular access for the dialysis machine; the most common type of vascular access is called an arteriovenous fistula (AVF). The AVF is a direct connect between an artery and vein.
Until recently, AVFs were only created through surgery that requires general anesthesia and opening up the skin. Now there are 2 FDA-approved devices designed to create AVFs using endovascular techniques (endoAVF), which means a device that goes through the skin instead of opening the skin up. Also patients are not required to be under general anesthesia, they can receive local anesthesia instead. Due to the relatively new approval of these devices, there is not a randomized study to compare the results of endoAVF versus surgAVF.
This study is a pilot study for an eventually larger scale study to compare the results of endoAVF versus surgAVF. The study aims to determine what the proportion of patients seeking hemodialysis access could qualify for receiving either an endoAVF , surgAVF, or both. Patients who are screened for hemodialysis access must undergo a duplex ultrasound of the blood vessels in the arm to confirm correct sizing. If participants qualify for both procedures they will be randomized to either endoAVF or surgAVF and will track the clinical and patient-reported outcomes of each procedure. Our pilot study hopes to enroll 90 participants. Those outcomes will inform a larger scale study. If the potential participant chooses to abstain from participation in the randomized trial, preferring to decide the method of AVF creation, we will offer to them a chance to join an endoAVF/surgAVF registry that will track the clinical outcomes of the procedure via medical record monitoring.
Read the detailed description
All individuals being considered for a AVF undergo a procedure called vein mapping. Vein mapping is a duplex ultrasound image of the upper extremity veins to determine whether the veins are suitable for a fistula, the veins have to be large enough with an upper arm vein diameter of ≥ 2.0 mm. The vein mapping is considered standard of care as part of the pre-operative evaluation for vascular access creation.
Potential subjects will have their duplex ultrasound imaging pre-screened to determine whether study anatomical suitability has been met. The vascular surgeons will make the final determination that the patient is a good candidate for a fistula. Those who pass the pre-screen for both endoAVF and surgAVF will be approached at their vascular access appointment to join the trial. If the subject agrees to join and is consented they will be screened further to determine if all other inclusionary/exclusionary criteria have been met, and if screening is satisfactory patients will be randomized by a computer with 50/50 chance of receiving either endoAVF and surgAVF. Those randomized to endoAVF will have to undergo an additional duplex ultrasound imaging that maps the distance between the artery and vein. For subjects who are randomized to endoAVF and who qualify for both devices (WavelinQ and Ellipsys), the decision of which device to use is left to the judgement of the treating physician. The additional vein mapping is done to determine which device can be used for the procedure. If this duplex ultrasound determines that the patient does not qualify for either device, they will be removed from the trial for their own safety and still be paid for the baseline visit. Once the participant has undergone surgery they will be followed for 2 years and undergo routine in-person follow-ups for the first 6 months that will gauge clinical and patient-reported outcomes and perform a physical examination of the fistula. The follow-up visits will be 35 days, 90 days, and 180 days after the initial surgery. The visits will take no more than 45 minutes to complete. There will be monthly chart reviews done to surveille for adverse events, which hemodialysis modality is used, and if secondary procedures are done to facilitate fistula maturation. The monthly chart reviews will happen until the end of the two year period.
Subjects who have signed the consent form yet choose to join the registry instead of the randomized trial will not undergo any extra in-person visits beyond obtaining the initial consent and PHI access authorization as well as a completing a questionnaire on their general vascular access experience which should take no more than 10-15 minutes to complete. The participants will have the clinical outcome of their index endoAVF or surgAVF procedure tracked for up to three years with regular medical record data abstraction
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- endoAVF, surgAVF
- Keywords
- hemodialysis, arteriovenous fistula, fistula, endoAVF, End Stage Renal Disease
- Medical subject headings
- Arteriovenous Fistula, Fistula, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoAVFDevice
Also called endovascular AVF
The device will be used according to manufactures instructions and medical facilities standard of care. EndoAVF has a high likelihood of requiring additional procedures that would not have been required if they had undergone surgAVF.
surgAVFProcedure or surgery
Also called surgical AVF
The surgAAVF procedure will be done according to the medical facilities standard of care. SurgAVF can also require additional procedures to help with the fistula being useable.
| Study group | Role | What they receive |
|---|---|---|
| surgAVF | Active comparator | Participant will undergo fistula creation through surgical means, which requires undergoing general anesthesia and opening the skin to create the fistula. Receives: Procedure: surgAVF |
| endoAVF | Active comparator | Participant will undergo fistula creation through endovascular surgical means, which does not require general anesthesia and is created by using a device that goes through the skin to create the fistula. The two devices that are currently FDA approved and used to create the endoAVF are the WavelinQ™ EndoAVF System and the Ellipsys® Vascular Access System. Receives: Device: endoAVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiologically mature fistula
flow ≥ 500 ml/min and internal diameter >0.5 cm
Measured: 6 months postoperatively
Secondary outcomes (6)
clinically mature
cannulate with 2 dialysis needles for 75% of dialysis sessions within a 4-week period and achieve the prescribed dialysis
Measured: 6 months
primary patency
Interval from time of access creation until any intervention to maintain or reestablish patency, access thrombosis, or end of study period, whichever comes first
Measured: 6 months
secondary patency
Interval from the time of access creation until access abandonment, including intervening interventions
Measured: 6 months
functional patency
Interval from time of access first use and access abandonment, including intervening interventions
Measured: 6 months
Number of interventions to achieve physiologic maturation
Endovascular \& surgical interventions required between access creation and physiologic maturation
Measured: 6 months
Number of interventions to achieve clinical maturation
Endovascular \& surgical interventions required between access creation and clinical maturation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start20 Nov 2024
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (57)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Model description
- Randomized controlled trial where participants are assigned to receive a fistula created through surgery (open the skin) or endovascular surgery (through the skin). There is the option to not join the randomized portion and instead join a registry that will track the outcome of a participants fistula.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Woo, MD, PhD, University of California, Los Angeles
- Investigators
- Karen Woo, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654103
- Sponsor's protocol ID
- IRB#22-001444
- Other IDs
- 1R01DK132422
- Status last verified
- Aug 2026
- First submitted
- 8 Dec 2022
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Yan Wee IJ, Yap HY, Tang TY, Chong TT. A systematic review, meta-analysis, and meta-regression of the efficacy and safety of endovascular arteriovenous fistula creation. J Vasc Surg. 2020 Jan;71(1):309-317.e5. doi: 10.1016/j.jvs.2019.07.057. Epub 2019 Sep 26.
PubMed 31564584Lok CE, Rajan DK, Clement J, Kiaii M, Sidhu R, Thomson K, Buldo G, Dipchand C, Moist L, Sasal J; NEAT Investigators. Endovascular Proximal Forearm Arteriovenous Fistula for Hemodialysis Access: Results of the Prospective, Multicenter Novel Endovascular Access Trial (NEAT). Am J Kidney Dis. 2017 Oct;70(4):486-497. doi: 10.1053/j.ajkd.2017.03.026. Epub 2017 Jun 14.
PubMed 28624422Brescia MJ, Cimino JE, Appell K, Hurwich BJ, Scribner BH. Chronic hemodialysis using venipuncture and a surgically created arteriovenous fistula. 1966. J Am Soc Nephrol. 1999 Jan;10(1):193-9. No abstract available.
PubMed 9890327Woodside KJ, Bell S, Mukhopadhyay P, Repeck KJ, Robinson IT, Eckard AR, Dasmunshi S, Plattner BW, Pearson J, Schaubel DE, Pisoni RL, Saran R. Arteriovenous Fistula Maturation in Prevalent Hemodialysis Patients in the United States: A National Study. Am J Kidney Dis. 2018 Jun;71(6):793-801. doi: 10.1053/j.ajkd.2017.11.020. Epub 2018 Feb 9.
PubMed 29429750Dember LM, Beck GJ, Allon M, Delmez JA, Dixon BS, Greenberg A, Himmelfarb J, Vazquez MA, Gassman JJ, Greene T, Radeva MK, Braden GL, Ikizler TA, Rocco MV, Davidson IJ, Kaufman JS, Meyers CM, Kusek JW, Feldman HI; Dialysis Access Consortium Study Group. Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA. 2008 May 14;299(18):2164-71. doi: 10.1001/jama.299.18.2164.
PubMed 18477783Lee T, Qian JZ, Zhang Y, Thamer M, Allon M. Long-Term Outcomes of Arteriovenous Fistulas with Unassisted versus Assisted Maturation: A Retrospective National Hemodialysis Cohort Study. J Am Soc Nephrol. 2019 Nov;30(11):2209-2218. doi: 10.1681/ASN.2019030318. Epub 2019 Oct 14.
PubMed 31611240Mallios A, Jennings WC, Boura B, Costanzo A, Bourquelot P, Combes M. Early results of percutaneous arteriovenous fistula creation with the Ellipsys Vascular Access System. J Vasc Surg. 2018 Oct;68(4):1150-1156. doi: 10.1016/j.jvs.2018.01.036. Epub 2018 Apr 19.
PubMed 29680297Hull JE, Elizondo-Riojas G, Bishop W, Voneida-Reyna YL. Thermal Resistance Anastomosis Device for the Percutaneous Creation of Arteriovenous Fistulae for Hemodialysis. J Vasc Interv Radiol. 2017 Mar;28(3):380-387. doi: 10.1016/j.jvir.2016.10.033. Epub 2016 Dec 29.
PubMed 28041783Beaulieu RJ, Locham S, Nejim B, Dakour-Aridi H, Woo K, Malas MB. General anesthesia is associated with reduced early failure among patients undergoing hemodialysis access. J Vasc Surg. 2019 Mar;69(3):890-897.e5. doi: 10.1016/j.jvs.2018.05.247.
PubMed 30798844Lok CE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, Allon M, Asif A, Astor BC, Glickman MH, Graham J, Moist LM, Rajan DK, Roberts C, Vachharajani TJ, Valentini RP; National Kidney Foundation. KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update. Am J Kidney Dis. 2020 Apr;75(4 Suppl 2):S1-S164. doi: 10.1053/j.ajkd.2019.12.001. Epub 2020 Mar 12.
PubMed 32778223Inston N, Khawaja A, Tullett K, Jones R. WavelinQ created arteriovenous fistulas versus surgical radiocephalic arteriovenous fistulas? A single-centre observational study. J Vasc Access. 2020 Sep;21(5):646-651. doi: 10.1177/1129729819897168. Epub 2020 Jan 2.
PubMed 31894716Berland TL, Clement J, Griffin J, Westin GG, Ebner A. Endovascular Creation of Arteriovenous Fistulae for Hemodialysis Access with a 4 Fr Device: Clinical Experience from the EASE Study. Ann Vasc Surg. 2019 Oct;60:182-192. doi: 10.1016/j.avsg.2019.02.023. Epub 2019 May 8.
PubMed 31075457Franco G, Mallios A, Bourquelot P, Hebibi H, Jennings W, Boura B. Feasibility for arteriovenous fistula creation with Ellipsys(R). J Vasc Access. 2020 Sep;21(5):701-704. doi: 10.1177/1129729819900114. Epub 2020 Jan 13.
PubMed 31928135Jones RG, Morgan RA. A Review of the Current Status of Percutaneous Endovascular Arteriovenous Fistula Creation for Haemodialysis Access. Cardiovasc Intervent Radiol. 2019 Jan;42(1):1-9. doi: 10.1007/s00270-018-2037-6. Epub 2018 Jul 20.
PubMed 30030582Vascular Access Work Group. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S248-73. doi: 10.1053/j.ajkd.2006.04.040. No abstract available.
PubMed 16813991
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing endoAVF Versus surgAVF
- ClinicalTrials.gov ID
- NCT05654103
- Acronym / sponsor ID
- IRB#22-001444
- Conditions
- End Stage Renal Disease on Dialysis
- Keywords
- hemodialysis, arteriovenous fistula, fistula, endoAVF, End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 16 Dec 2022 (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.
Patients with end-stage kidney disease (ESKD) who use hemodialysis to filter their blood require vascular access for the dialysis machine; the most common type of vascular access is called an arteriovenous fistula (AVF). The AVF is a direct connect between an artery and vein.
Until recently, AVFs were only created through surgery that requires general anesthesia and opening up the skin. Now there are 2 FDA-approved devices designed to create AVFs using endovascular techniques (endoAVF), which means a device that goes through the skin instead of opening the skin up. Also patients are not required to be under general anesthesia, they can receive local anesthesia instead. Due to the relatively new approval of these devices, there is not a randomized study to compare the results of endoAVF versus surgAVF.
This study is a pilot study for an eventually larger scale study to compare the results of endoAVF versus surgAVF. The study aims to determine what the proportion of patients seeking hemodialysis access could qualify for receiving either an endoAVF , surgAVF, or both. Patients who are screened for hemodialysis access must undergo a duplex ultrasound of the blood vessels in the arm to confirm correct sizing. If participants qualify for both procedures they will be randomized to either endoAVF or surgAVF and will track the clinical and patient-reported outcomes of each procedure. Our pilot study hopes to enroll 90 participants. Those outcomes will inform a larger scale study. If the potential participant chooses to abstain from participation in the randomized trial, preferring to decide the method of AVF creation, we will offer to them a chance to join an endoAVF/surgAVF registry that will track the clinical outcomes of the procedure via medical record monitoring.
Detailed description
All individuals being considered for a AVF undergo a procedure called vein mapping. Vein mapping is a duplex ultrasound image of the upper extremity veins to determine whether the veins are suitable for a fistula, the veins have to be large enough with an upper arm vein diameter of ≥ 2.0 mm. The vein mapping is considered standard of care as part of the pre-operative evaluation for vascular access creation.
Potential subjects will have their duplex ultrasound imaging pre-screened to determine whether study anatomical suitability has been met. The vascular surgeons will make the final determination that the patient is a good candidate for a fistula. Those who pass the pre-screen for both endoAVF and surgAVF will be approached at their vascular access appointment to join the trial. If the subject agrees to join and is consented they will be screened further to determine if all other inclusionary/exclusionary criteria have been met, and if screening is satisfactory patients will be randomized by a computer with 50/50 chance of receiving either endoAVF and surgAVF. Those randomized to endoAVF will have to undergo an additional duplex ultrasound imaging that maps the distance between the artery and vein. For subjects who are randomized to endoAVF and who qualify for both devices (WavelinQ and Ellipsys), the decision of which device to use is left to the judgement of the treating physician. The additional vein mapping is done to determine which device can be used for the procedure. If this duplex ultrasound determines that the patient does not qualify for either device, they will be removed from the trial for their own safety and still be paid for the baseline visit. Once the participant has undergone surgery they will be followed for 2 years and undergo routine in-person follow-ups for the first 6 months that will gauge clinical and patient-reported outcomes and perform a physical examination of the fistula. The follow-up visits will be 35 days, 90 days, and 180 days after the initial surgery. The visits will take no more than 45 minutes to complete. There will be monthly chart reviews done to surveille for adverse events, which hemodialysis modality is used, and if secondary procedures are done to facilitate fistula maturation. The monthly chart reviews will happen until the end of the two year period.
Subjects who have signed the consent form yet choose to join the registry instead of the randomized trial will not undergo any extra in-person visits beyond obtaining the initial consent and PHI access authorization as well as a completing a questionnaire on their general vascular access experience which should take no more than 10-15 minutes to complete. The participants will have the clinical outcome of their index endoAVF or surgAVF procedure tracked for up to three years with regular medical record data abstraction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial where participants are assigned to receive a fistula created through surgery (open the skin) or endovascular surgery (through the skin). There is the option to not join the randomized portion and instead join a registry that will track the outcome of a participants fistula.
| Arm | Type | Receives |
|---|---|---|
| surgAVF | Active comparator | Procedure: surgAVFParticipant will undergo fistula creation through surgical means, which requires undergoing general anesthesia and opening the skin to create the fistula. |
| endoAVF | Active comparator | Device: endoAVFParticipant will undergo fistula creation through endovascular surgical means, which does not require general anesthesia and is created by using a device that goes through the skin to create the fistula. The two devices that are currently FDA approved and used to create the endoAVF are the WavelinQ™ EndoAVF System and the Ellipsys® Vascular Access System. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ESKD patients aged ≥ 18 who have chosen hemodialysis as their renal replacement option.
- Ability to give consent to participate in a research study.
- Upper arm vein diameter of ≥ 2.0 mm.
- Confirmed radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by preprocedural ultrasound and confirmed pre-procedurally.
- Confirmed radial artery and adjacent vein diameter of ≥ 2.0 mm at site where vein and artery connects.
Key exclusion criteria (7 listed)
- People under the age of 18.
- Inability to understand the consent process and/or give consent.
- Upper arm vein diameter less than 2.0 mm making them unsuitable to receive an surgAVF AND endoAVF.
- Patients who are deemed by the surgeon to be anatomic candidates for a forearm vascular access, and the surgeon and the patient determine that a forearm access is the optimal access for the patient, in order to preserve more proximal anatomic sites for future accesses.
- Currently incarcerated individuals.
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 |
|---|---|---|
| endoAVFAlso: endovascular AVFThe device will be used according to manufactures instructions and medical facilities standard of care. EndoAVF has a high likelihood of requiring additional procedures that would not have been required if they had undergone surgAVF. | Device | endoAVF |
| surgAVFAlso: surgical AVFThe surgAAVF procedure will be done according to the medical facilities standard of care. SurgAVF can also require additional procedures to help with the fistula being useable. | Procedure or surgery | surgAVF |
Primary outcome
Physiologically mature fistula
Time frame: 6 months postoperatively
flow ≥ 500 ml/min and internal diameter >0.5 cm
6 secondary outcomes
clinically mature
Time frame: 6 months
primary patency
Time frame: 6 months
secondary patency
Time frame: 6 months
functional patency
Time frame: 6 months
Number of interventions to achieve physiologic maturation
Time frame: 6 months
Number of interventions to achieve clinical maturation
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Background: PubMed 31564584Yan Wee IJ, Yap HY, Tang TY, Chong TT. A systematic review, meta-analysis, and meta-regression of the efficacy and safety of endovascular arteriovenous fistula creation. J Vasc Surg. 2020 Jan;71(1):309-317.e5. doi: 10.1016/j.jvs.2019.07.057. Epub 2019 Sep 26.
- Background: PubMed 28624422Lok CE, Rajan DK, Clement J, Kiaii M, Sidhu R, Thomson K, Buldo G, Dipchand C, Moist L, Sasal J; NEAT Investigators. Endovascular Proximal Forearm Arteriovenous Fistula for Hemodialysis Access: Results of the Prospective, Multicenter Novel Endovascular Access Trial (NEAT). Am J Kidney Dis. 2017 Oct;70(4):486-497. doi: 10.1053/j.ajkd.2017.03.026. Epub 2017 Jun 14.
- Background: PubMed 9890327Brescia MJ, Cimino JE, Appell K, Hurwich BJ, Scribner BH. Chronic hemodialysis using venipuncture and a surgically created arteriovenous fistula. 1966. J Am Soc Nephrol. 1999 Jan;10(1):193-9. No abstract available.
- Background: PubMed 29429750Woodside KJ, Bell S, Mukhopadhyay P, Repeck KJ, Robinson IT, Eckard AR, Dasmunshi S, Plattner BW, Pearson J, Schaubel DE, Pisoni RL, Saran R. Arteriovenous Fistula Maturation in Prevalent Hemodialysis Patients in the United States: A National Study. Am J Kidney Dis. 2018 Jun;71(6):793-801. doi: 10.1053/j.ajkd.2017.11.020. Epub 2018 Feb 9.
- Background: PubMed 18477783Dember LM, Beck GJ, Allon M, Delmez JA, Dixon BS, Greenberg A, Himmelfarb J, Vazquez MA, Gassman JJ, Greene T, Radeva MK, Braden GL, Ikizler TA, Rocco MV, Davidson IJ, Kaufman JS, Meyers CM, Kusek JW, Feldman HI; Dialysis Access Consortium Study Group. Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA. 2008 May 14;299(18):2164-71. doi: 10.1001/jama.299.18.2164.
- Background: PubMed 31611240Lee T, Qian JZ, Zhang Y, Thamer M, Allon M. Long-Term Outcomes of Arteriovenous Fistulas with Unassisted versus Assisted Maturation: A Retrospective National Hemodialysis Cohort Study. J Am Soc Nephrol. 2019 Nov;30(11):2209-2218. doi: 10.1681/ASN.2019030318. Epub 2019 Oct 14.
- Background: PubMed 29680297Mallios A, Jennings WC, Boura B, Costanzo A, Bourquelot P, Combes M. Early results of percutaneous arteriovenous fistula creation with the Ellipsys Vascular Access System. J Vasc Surg. 2018 Oct;68(4):1150-1156. doi: 10.1016/j.jvs.2018.01.036. Epub 2018 Apr 19.
- Background: PubMed 28041783Hull JE, Elizondo-Riojas G, Bishop W, Voneida-Reyna YL. Thermal Resistance Anastomosis Device for the Percutaneous Creation of Arteriovenous Fistulae for Hemodialysis. J Vasc Interv Radiol. 2017 Mar;28(3):380-387. doi: 10.1016/j.jvir.2016.10.033. Epub 2016 Dec 29.
- Background: PubMed 30798844Beaulieu RJ, Locham S, Nejim B, Dakour-Aridi H, Woo K, Malas MB. General anesthesia is associated with reduced early failure among patients undergoing hemodialysis access. J Vasc Surg. 2019 Mar;69(3):890-897.e5. doi: 10.1016/j.jvs.2018.05.247.
- Background: PubMed 32778223Lok CE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, Allon M, Asif A, Astor BC, Glickman MH, Graham J, Moist LM, Rajan DK, Roberts C, Vachharajani TJ, Valentini RP; National Kidney Foundation. KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update. Am J Kidney Dis. 2020 Apr;75(4 Suppl 2):S1-S164. doi: 10.1053/j.ajkd.2019.12.001. Epub 2020 Mar 12.
- Background: PubMed 31894716Inston N, Khawaja A, Tullett K, Jones R. WavelinQ created arteriovenous fistulas versus surgical radiocephalic arteriovenous fistulas? A single-centre observational study. J Vasc Access. 2020 Sep;21(5):646-651. doi: 10.1177/1129729819897168. Epub 2020 Jan 2.
- Background: PubMed 31075457Berland TL, Clement J, Griffin J, Westin GG, Ebner A. Endovascular Creation of Arteriovenous Fistulae for Hemodialysis Access with a 4 Fr Device: Clinical Experience from the EASE Study. Ann Vasc Surg. 2019 Oct;60:182-192. doi: 10.1016/j.avsg.2019.02.023. Epub 2019 May 8.
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End-Stage Renal Disease, Renal Dialysis
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
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.
Karen Woo, MD, PhD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoAVF and surgAVF in people with End Stage Renal Disease on Dialysis, run by University of California, Los Angeles at 2 sites 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 8 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Physiologically mature fistula (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05654103, which also lists 57 linked publications.
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 10 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.