AngioDynamics Initiates AMBITION BTK Trial of Auryon System for CLI

January 30, 2025—AngioDynamics, Inc. announced the commencement of the AMBITION BTK multicenter randomized controlled trial (RCT), which will evaluate clinical outcomes of the company’s Auryon atherectomy system used in combination with standard balloon angioplasty versus standard balloon angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia (CLI) below the knee (BTK).

According to the company, the AMBITION BTK trial will enroll up to 200 patients at up to 30 hospital-based sites. Additionally, up to 1,500 patients treated with the Auryon atherectomy system at the same sites who do not meet the RCT eligibility criteria will be enrolled in a companion registry.

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

“With the global rise in diabetes, we are seeing a growing number of patients with severe tibial disease,” commented Dr. Dua in AngioDynamics’ press release. “In the United States, treatment options for BTK lesions remain limited, often relying primarily on plain old balloon angioplasty. These patients frequently present with tibial disease that can extend throughout the entire vessel. An innovative tool like the Auryon laser, which can restore laminar flow, could be a game changer in their care.”

Dr. Armstrong added, “The AMBITION BTK RCT and registry represent an important advance in the evidence supporting the benefits of laser atherectomy in achieving acute and long-term procedural success. The trial will address an important unmet need for patients with CLI and tibial artery disease. The data for the trial will also help better understand the Auryon laser’s unique mechanism of action in complex and calcified lesions.”

AngioDynamics stated that AMBITION BTK builds on the positive outcomes of a previous multicenter prospective trial that evaluated the safety and effectiveness of the Auryon laser atherectomy system in treating BTK lesions in patients with limb ischemia. The findings from that study led to the development of the AMBITION BTK RCT and registry.

The earlier study (AURYON BTK, which commenced in April 2022) treated 61 complex calcified lesions in 60 patients enrolled at four centers in the United States. The study achieved strong clinical outcomes with minimal complications, demonstrating the system’s ability to safely and effectively address challenging BTK cases, reported the company.

AngioDynamics also announced that on February 1, it will host its inaugural Cardiovascular Scientific Forum, which will bring together leading physicians and thought leaders in the cardiovascular field to present research, discuss emerging clinical trends, and showcase advancements shaping the future of patient care, including the AMBITION BTK RCT and registry.

As noted in the press release, Auryon uses a 355-nm wavelength laser platform that enables the use of short ultraviolet laser pulses with targeted biological reactions that are effective in treating peripheral artery disease while minimizing the risk of perforation and preserving the ability to vaporize lesions without thermal ablation.

The technology has been shown in clinical studies to be effective in treating lesions ranging from soft plaque to severely calcified. The Auryon laser can be used to treat all infrainguinal lesion types, including BTK, above the knee, and in-stent restenosis, advised AngioDynamics.