AngioDynamics today announced the initiation of AMBITION BTK, a randomised study of the Auryon atherectomy system in the treatment of below-the-knee (BTK) chronic limb-threatening ischaemia (CLTI).
AMBITION BTK is a multicentre, randomised controlled trial (RCT) designed to evaluate the clinical outcomes of the Auryon atherectomy system in combination with standard balloon angioplasty compared to standard balloon angioplasty alone for the treatment of infrapopliteal lesions in patients with CLTI. The trial will enrol up to 200 patients across 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 eligibility criteria of the RCT will be enrolled in a companion registry.
“We are dedicated to expanding innovative treatment options for peripheral arterial disease, particularly in challenging cases like below-the-knee lesions,” said Juan Carlos Serna, AngioDynamics senior vice president of scientific and clinical affairs. “The AMBITION BTK RCT and registry represent an important advancement in evaluating the clinical benefits of the Auryon atherectomy system. Physicians have expressed strong interest in the platform’s unique capabilities, and we are eager to demonstrate further its potential to improve outcomes for patients with chronic limb-threatening ischaemia.”
A press release notes that the Auryon laser can be used to treat all infrainguinal lesion types, including above-the-knee (ATK), BTK and in-stent restenosis (ISR) and to date, it has been used to treat more than 100,000 patients in the USA and worldwide.
“With the global rise in diabetes, we are seeing a growing number of patients with severe tibial disease,” said AMBITION BTK co-principal investigator Anahita Dua (Massachusetts General Hospital and Harvard Medical School, Boston, USA). “In the USA, treatment options for below-the-knee lesions remain limited, often relying primarily on plain 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 gamechanger in their care.”
AMBITION BTK builds upon the positive outcomes of a prior multicentre, prospective trial that evaluated the safety and effectiveness of the Auryon laser atherectomy system in treating BTK lesions in patients with limb ischaemia. The earlier study successfully treated 61 complex, calcified lesions in 60 patients across four US centres, achieving strong clinical outcomes with minimal complications. These results demonstrated the system’s ability to safely and effectively address challenging BTK cases, leading to the development of the AMBITION BTK RCT and registry.
“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,” said AMBITION BTK co-principal investigator Ehrin Armstrong (Adventist Heart and Vascular Institute, St Helena, USA). “The trial will address an important unmet need for patients with chronic limb-threatening ischaemia 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.”
