endoAVF vs surgAVF for Chronic Kidney Failure

Recruiting at 1 trial location

Overseen By Jenny Lester, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Los Angeles

Disqualifiers: Under 18, Pregnant, Peritoneal dialysis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment endoAVF for Chronic Kidney Failure?

Research shows that endovascular arteriovenous fistulas (endoAVFs) created using devices like Ellipsys and WavelinQ are effective for dialysis access in patients with kidney failure. These devices have been successfully used to create AVFs, which are essential for dialysis, and studies have reported positive outcomes in terms of success rates and short-term follow-up. ^{1 2 3 4 5}

Is the endoAVF procedure safe for humans?

The WavelinQ endoAVF system, used to create a connection between veins and arteries for dialysis, has been approved by the FDA and used in patients, indicating it meets safety standards. However, some cases have reported failures shortly after the procedure, suggesting that while generally safe, there may be risks of complications. ^{1 2 3 5 6}

How does the endoAVF treatment differ from other treatments for chronic kidney failure?

The endoAVF treatment is unique because it offers a minimally invasive way to create an arteriovenous fistula (AVF) for dialysis access, using devices like WavelinQ and Ellipsys, compared to the traditional surgical method. This approach may be less invasive and potentially more convenient for patients, although more data is needed to fully compare its effectiveness to surgical AVFs. ^{1 2 4 5 7}

Research Team

Karen Woo, MD, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for adults over 18 with end-stage kidney disease who need hemodialysis and have veins in their arms suitable for creating a vascular access. They must be able to consent to the study, not pregnant, nor planning pregnancy within six months, and not opting for peritoneal dialysis or a kidney transplant soon.

Inclusion Criteria

The vein and artery where the device will be used need to be a certain size and be a specific distance apart from each other.

The vein and artery where they connect are at least 2.0 mm in diameter.

Ability to give consent to participate in a research study.

Exclusion Criteria

Currently incarcerated individuals.

I understand the consent process and can give my consent.

My upper arm veins are too small for certain vein surgeries.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative Evaluation

Vein mapping and duplex ultrasound imaging to determine anatomical suitability for AVF creation

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo either endoAVF or surgAVF procedure based on randomization

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with routine follow-ups and monthly chart reviews

2 years

3 visits (in-person) at 35, 90, and 180 days; monthly chart reviews

Registry Follow-up (optional)

Participants who opt for the registry have their clinical outcomes tracked via medical record data abstraction

3 years

Treatment Details

Interventions

• endoAVF (Procedure)
• surgAVF (Surgery)

Trial Overview The study compares two methods of arteriovenous fistula (AVF) creation: traditional surgery (surgAVF) and a newer endovascular technique (endoAVF). Participants eligible for both will be randomly assigned to one method. The outcomes will help design a larger future study.

Participant Groups

Group I: surgAVF Active Control 1 Intervention

Participant will undergo fistula creation through surgical means, which requires undergoing general anesthesia and opening the skin to create the fistula.

Group II: endoAVF Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Percutaneous creation of arteriovenous fistulas (AVFs) using Ellipsys or WavelinQ devices is a safe and effective alternative to traditional surgical methods, with comparable procedural success and complication rates based on a systematic review and meta-analysis of available studies.

However, the percutaneous approach significantly reduces procedural time and requires fewer interventions to maintain patency, suggesting it may offer practical advantages in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular Versus Surgical Arteriovenous Fistulas: A Systematic Review and Meta-analysis. Malik, MH., Mohammed, M., Kallmes, DF., et al.[2023]

The WavelinQ EndoAVF System demonstrated a 100% initial success rate in creating arteriovenous fistulas for dialysis access in 35 patients, with an average follow-up of 73 days showing an overall patency rate of 88%.

Despite the high initial success, 41% of patients required additional endovascular interventions to assist with fistula maturation, indicating that while the procedure is effective, further research is needed to understand factors that predict the need for these reinterventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Usage of the WavelinQ EndoAVF System. Zemela, MS., Minami, HR., Alvarez, AC., et al.[2021]

In a case study of a 66-year-old male with end-stage kidney disease, both the WavelinQ and Ellipsys systems for creating endovascular arteriovenous fistulas (pAVFs) initially failed, leading to the successful creation of a Gracz-type AVF that remained patent for 807 days without complications.

The findings suggest that attempting pAVF creation before a Gracz-AVF can be an effective strategy in vascular access planning, particularly for patients with complex medical histories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gracz fistula is a feasible option after two failed percutaneous arteriovenous fistulae. Shahverdyan, R., Konner, K., Matoussevitch, V.[2023]

Percutaneous arteriovenous fistulas (AVFs) for hemodialysis access, created using devices like the Ellipsys® and WavelinQ systems, represent a novel approach that may improve patient outcomes compared to traditional surgical methods.

The paper reviews the current use and effectiveness of these devices, highlighting their advantages and disadvantages, which can help guide the selection of the best access method for patients with end-stage renal disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Current Role of the Percutaneous Arteriovenous Fistula for Hemodialysis Access. Choinski, KN., Sundick, SA., Rao, AG., et al.[2020]

In a study of 437 patients referred for vascular access placement, 32% were found to have vascular anatomy suitable for the WavelinQ endovascular arteriovenous fistula (endoAVF), indicating a significant potential for this novel technique in patients with chronic kidney disease (CKD).

Younger patients (average age 55) were more likely to be suitable for the WavelinQ procedure compared to older patients (average age 60), suggesting that age may be a factor in determining eligibility for this innovative vascular access method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Creation of an Endovascular Arteriovenous Fistula in Patients Undergoing Preoperative Vascular Mapping. Al-Balas, A., Varma, R., Sharbidre, K., et al.[2023]

The creation of percutaneous arteriovenous fistulas (pAVFs) using the WavelinQ 4-F EndoAVF System showed a 100% technical success rate and an 86.7% cannulation rate in a study of 30 patients, indicating high efficacy for patients needing hemodialysis.

The procedure had a low adverse event rate of 6.7%, with long-term patency rates of 96% at 1 year and 82% at 2 and 3 years, suggesting that pAVF creation is a safe and effective option for vascular access in hemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Arteriovenous Fistula Creation with the WavelinQ 4-French EndoAVF System: A Single-Center Retrospective Analysis of 30 Patients. Kitrou, PM., Balta, L., Papachristou, E., et al.[2022]

Endovascular arteriovenous fistula (endoAVF) creation is a minimally invasive technique for forming arteriovenous shunts for hemodialysis, utilizing devices like WavelinQ and Ellipsys.

While there is limited data on the clinical efficacy of endoAVFs compared to traditional surgical AVFs, early results indicate that endoAVFs may be a promising option for creating these vital access points.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular Arteriovenous Fistula Creation: A Review. Tyagi, R., Ahmed, SS., Navuluri, R., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Endovascular Versus Surgical Arteriovenous Fistulas: A Systematic Review and Meta-analysis. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Real-World Usage of the WavelinQ EndoAVF System. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Gracz fistula is a feasible option after two failed percutaneous arteriovenous fistulae. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The Current Role of the Percutaneous Arteriovenous Fistula for Hemodialysis Access. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Creation of an Endovascular Arteriovenous Fistula in Patients Undergoing Preoperative Vascular Mapping. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Arteriovenous Fistula Creation with the WavelinQ 4-French EndoAVF System: A Single-Center Retrospective Analysis of 30 Patients. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Endovascular Arteriovenous Fistula Creation: A Review. [2022]