Comparing Surgical and Endovascular Arteriovenous Fistula Creation Study

Comparing Surgical and Endovascular Arteriovenous Fistula Creation 

About this study 

Background 

The most common type of vascular access for patients with end-stage kidney disease (ESKD) who use hemodialysis to filter their blood is called an arteriovenous fistula (AVF). The AVF is a direct connection between an artery and vein. Until recently, AVFs were only created through surgery. Now there are new tools approved by the FDA designed to create AVFs using endovascular techniques (endoAVF), which means a device goes through the skin instead of opening the skin up. Due to the newness of these devices, the medical community is not sure how endoAVF compares to traditional surgical AVF (surgAVF). This is a small pilot study to prepare for a future larger study to compare the results of endoAVF versus surgAVF. 

Goals 

The goal of our research is to determine what percentage of patients who need hemodialysis access can qualify to receive an endoAVF, surgAVF, or both. The study will track the clinical and patient-reported outcomes of each procedure. Additionally, the study is interested in determining patients’ willingness to participate in a randomized trial, barriers, and strategies to overcome the barriers. 

What to expect if you participate in the study 

If you’re being evaluated for dialysis access, you will need a special ultrasound (called a duplex ultrasound) to check the size and condition of your arm veins and arteries. 

You will be asked if you're willing to share the results of that ultrasound for research. This would help us see how many people are eligible for each type of AVF. This part of the study is called the Anatomic Cohort. 

If your blood vessels are suitable for either method (endoAVF or surgAVF), you may be invited to join a randomized controlled trial (RCT). In that study, you will be randomly assigned one of the two procedures. You’ll also be asked to fill out short surveys when you join the study and again at about 1 month (35 days), 3 months (90 days), and 6 months (180 days) after your procedure. 

If you prefer to choose which procedure you get (instead of being randomly assigned), you can join a registry, which means we’ll still track how things go for you after your procedure by reviewing your medical records. You can also choose to fill out the same surveys if you want. 

Patient participants should: 

  • Be 18 years of age or older 
  • Have end-stage kidney disease 
  • Have chosen hemodialysis as your kidney replacement option 

For more information

Questions? Email us at [email protected]