endoAVF vs surgAVF for Chronic Kidney Failure

This trial explores two methods to create an arteriovenous fistula (AVF), a vital connection between an artery and a vein for patients with end-stage kidney disease requiring hemodialysis. Traditionally, surgeons create AVFs, but a less invasive method now uses endovascular techniques, avoiding general anesthesia and involving a device that passes through the skin. The trial compares outcomes of the traditional surgical method (surgAVF) with the newer method (endoAVF, or Endovascular Arteriovenous Fistula) to determine which is more effective or preferable for patients. Individuals who have chosen hemodialysis and have suitable arm vein sizes may qualify to participate. As an unphased trial, this study allows patients to contribute to medical advancements and potentially benefit from innovative treatment options.

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.

Research shows that creating an endovascular arteriovenous fistula (endoAVF) is generally well-tolerated by patients. A review of studies found that endoAVF procedures are safe and have few side effects. Patients undergoing this treatment often experience fewer complications compared to traditional surgery. Additionally, endoAVF does not require general anesthesia, reducing anesthesia-related risks.

The FDA has approved devices used for endoAVF, such as the WavelinQ™ and Ellipsys® systems, indicating they meet safety standards. While researchers continue to collect long-term safety data, early results are encouraging.

In contrast, surgAVF involves surgery with general anesthesia, which can lead to more risks, such as infections or anesthesia-related issues. However, both methods create arteriovenous fistulas, essential for patients on dialysis.

Researchers are excited about endoAVF and surgAVF because they offer innovative ways to create arteriovenous fistulas for patients with chronic kidney failure. EndoAVF is particularly unique due to its minimally invasive approach, using devices like the WavelinQ™ EndoAVF System and the Ellipsys® Vascular Access System. This method avoids the need for general anesthesia and large incisions, unlike traditional surgical methods. On the other hand, surgAVF requires a more invasive surgical procedure with general anesthesia, which is the current standard of care. Both treatments aim to improve patient outcomes and comfort, making them promising options for those requiring dialysis access.

This trial will compare the effectiveness of endoAVF (endovascular arteriovenous fistula) with surgAVF (surgical arteriovenous fistula) for patients needing hemodialysis. Research has shown that creating an endoAVF is promising, as it avoids major surgery by using devices to connect blood vessels through the skin and requires only local anesthesia. Studies have found that endoAVFs are successful and remain open over time, similar to traditional surgical AVFs. They are also considered safe, with fewer surgery-related complications. These findings suggest that endoAVF could effectively serve as an alternative to surgAVF for creating the access needed for dialysis.¹²⁴⁵⁶