AngioDynamics AMBITION BTK Trial Begins Enrollment

July 28, 2025—AngioDynamics, Inc. announced enrollment of the first patient in the AMBITION BTK study of the Auryon atherectomy system.

According to the company, AMBITION BTK is a prospective, multicenter, randomized controlled trial (RCT) designed to investigate the clinical safety and effectiveness of the Auryon system combined with standard balloon angioplasty versus balloon angioplasty alone in treating infrapopliteal lesions in patients with critical limb ischemia (CLI) below the knee.

AngioDynamics advised that the primary endpoint of the study will be evaluated using a win-ratio approach, comparing the two treatment groups based on the following components in a hierarchical manner at 12 months: freedom from major amputation, freedom from clinically driven target lesion revascularization, and primary patency.

The company stated that the RCT will include up to 224 patients at up to 30 sites. A parallel companion registry will enroll up to 1,500 additional patients who are ineligible for the RCT and are treated with the Auryon system above or below the knee.

Anahita Dua, MD, and Ehrin Armstrong, MD, are Coprincipal Investigators of the AMBITION BTK RCT.

Dr. Dua is a vascular surgeon at Massachusetts General Hospital and Associate Professor of Surgery at Harvard Medical School in Boston, Massachusetts. Dr. Armstrong is an interventional cardiologist and Director of Clinical Research at Advanced Heart and Vein Center in Denver, Colorado.

“Treatment options for below-the-knee (BTK) lesions are still limited and often depend heavily on balloon angioplasty,” commented Dr. Armstrong in the company’s press release. “The Auryon laser can restore laminar flow and therefore has the potential to improve outcomes in this challenging patient population significantly.”

Dr. Dua, who treated the first patient in the trial, added, “I’m excited to perform the first patient case in the AMBITION BTK study. Patients with BTK disease often face limited treatment options and poor long-term outcomes.”

Dr. Dua continued, “Across the world, there has been a significant increase in patients with BTK disease, which is, unfortunately, resulting in an amputation epidemic. Having new tools and techniques to restore blood flow to the foot, allowing wounds to heal and patients to preserve both their limbs and lives, is critically important and the focus of this trial. This trial will allow us to collect high-quality, real-world data using a robust research design, helping us truly evaluate the impact of laser technology in BTK disease.”

The Auryon laser can be used to treat all infrainguinal lesion types, including above the knee, in-stent restenosis, and below the knee, noted the AngioDynamics press release.