Houston Methodist Leads the Way in Groundbreaking Arteriovenous Fistulas Trial

Houston Methodist Hospital is at the forefront of a groundbreaking clinical trial aimed at improving outcomes for hemodialysis patients requiring arteriovenous fistulas (AVFs).

The SAVE Fistulas trial, a first-of-its-kind, randomized controlled study, is evaluating VenoStent's SelfWrap, a bioabsorbable wrap designed to improve the success rate of fistulas in patients with chronic kidney disease (CKD).

"Arteriovenous fistulas of native vessels are preferred over prosthetic grafts and central venous catheters because they are the most durable access points and are associated with lower mortality, infections and cardiovascular events," said Dr. Eric Peden, chief of vascular surgery at Houston Methodist Hospital and co-national principal investigator of the trial. "However, they are also associated with high rates of failure because they increase the size of a vein by three to four times and the pressure in the vein up to ten-fold, something the human body may or may not accommodate."

The objective of the 200-patient, prospective, one-to-one controlled SAVE Fistulas trial is to reduce the nearly 60 percent AVF failure rate by lending structural support to the vein during the critical early weeks of maturation.

"If we can reduce the failure rate from 60 percent to 30 percent, that would be a major step forward for patients," Dr. Peden said.

The innovative SelfWrap technology, developed by VenoStent, mimics the arterial environment, helping veins adapt to the increased pressure and flow caused by their connection to an artery.

Unlike previous non-biodegradable devices, SelfWrap is designed to be absorbed by the body, avoiding long-term complications.

"Fistulas fail because the vein shrinks rather than grows, preventing the access from becoming viable for dialysis," Dr. Peden explained. "Dialysis requires blood to be removed, cleaned and returned to the patient's body at a rate of about 500 cubic centimeters per minute, for three to four hours at a time, three times a week. That is a very large volume, much more than a normal vein or IV can handle."

The trial is expected to provide the highest level of clinical evidence required for FDA approval.

Dr. Peden emphasized the importance of the randomized controlled trial.

"There's a reason it's the gold standard, and that's because it's the most effective way to minimize selection bias and prove cause and effect, but it's also a much higher bar to clear," said Dr. Peden. "I'm proud to be associated with the first-ever randomized controlled trial of a medical device designed to improve outcomes from arteriovenous fistula creation surgery in the United States."

The trial's results could mark a turning point in dialysis access management, particularly as the dialysis population continues to grow older and sicker.

"This is a patient group with historically poor outcomes, and we need innovation to change that," Dr. Peden emphasized. "Since the first fistula creation surgeries of the 1960s, there have been drugs, devices and new approaches attempting to reduce AVF failure rates, but none have ever definitively been proven to do so."

The SAVE Fistulas trial is being conducted across multiple sites in the United States, with Houston Methodist playing a leading role in patient enrollment and data collection.

If successful, the study could pave the way for broader adoption of SelfWrap and improved standards in vascular access care for dialysis patients.

"Houston Methodist is not only the lead enrolling site, and the first to hit the cap of randomizing 30 patients into the trial, but we have been involved in developing this technology since its earliest days," said Dr. Peden, alluding to a years-long collaboration with Timothy Boire, VenoStent co-founder and CEO.

Boire in 2021 brought his idea to Houston Methodist's Center for Rapid Device Translation, a unique preclinical research, development and testing service that provides outside entrepreneurs with the resources of a major academic medical center to help bring promising medical advancements to market sooner.

"It's a compelling home-grown success story — hopefully one that comes full-circle soon, pending results of the trial," Dr. Peden explained. "It's very exciting to see this technology which is so sorely needed progress toward real-world application."