Enrollment begun in study of DCB for treatment of arteriovenous fistulas in renal disease

Medtronic announced the first patient has been enrolled in a study of a drug-coated balloon to treat failing arteriovenous fistulas in patients with end-stage renal disease.

According to a press release from the company, the IN.PACT AV Access DCB study was recently approved as an investigational device exemption study by the FDA.

“Maintaining access patency is critical to delivering dialysis treatment, and for salvaging [arteriovenous] fistulas,” investigator Jeffrey Hull, MD, from Richmond Vascular Center, Richmond, Virginia, said in the release. “Durable treatment options in these patients are limited.”

The study aims to enroll 330 patients with a 1:1 randomization to treatment with either the DCB (IN.PACT AV Access, Medtronic) or standard percutaneous transluminal angioplasty, according to the release.

The primary safety endpoint is serious adverse events at 30 days. The primary efficacy endpoint is patency of dialysis fistulas at 6 months.

“This important clinical study is designed to address the clinical need for new, innovative options for patients with limited [arteriovenous] access,” Robert A. Lookstein, MD, national principal investigator in the U.S. and professor of radiology and surgery, vice chair of interventional services and medical director of clinical supply chain at Mount Sinai Healthcare System, said in the release. “We hope that this study may provide data to support this DCB’s use to improve patency and reduce the need for repeat interventions in [arteriovenous] access for patients on dialysis.”

Disclosure: Hull reports consulting for Avenu Medical and serving as an investigator for a trial sponsored by Medtronic. Lookstein reports consulting for Boston Scientific, Cordis and Medrad, serving on an advisory board and serving as national principal investigator for a trial sponsored by Medtronic.