AngioDynamics today announced enrollment of the first patient in AMBITION BTK, a randomized study of the Auryon atherectomy system in patients with below-the-knee chronic limb-threatening ischemia (CLTI).
A press release details that AMBITION BTK is a prospective, multicenter, randomized controlled trial (RCT) designed to investigate the clinical safety and effectiveness of the Auryon atherectomy system combined with standard balloon angioplasty, compared to balloon angioplasty alone, in treating infrapopliteal lesions in patients with CLTI. The primary endpoint 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 (CD-TLR), and primary patency.
The RCT will include up to 224 patients at up to 30 sites. In parallel, a 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.
The first patient in the trial was treated by Anahita Dua, MD, a vascular surgeon at Massachusetts General Hospital and Harvard Medical School in Boston, co-principal investigator of AMBITION BTK.
“I’m excited to perform the first patient case in the AMBITION BTK study. Patients with below-the-knee disease often face limited treatment options and poor long-term outcomes,” said Dua. “Across the world, there has been a significant increase in patients with below-the-knee (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.”
