AngioDynamics has enrolled the first patient in the AMBITION BTK trial, investigating its Auryon Atherectomy System in treating critical limb ischemia (CLI).
The trial aims to assess the clinical safety and efficacy of combining the Auryon Atherectomy System with standard balloon angioplasty compared to angioplasty alone.
AMBITION BTK is a multicentre, randomised controlled trial (RCT) designed to enrol up to 224 patients across 30 sites, and evaluate the primary endpoint using a win-ratio approach.
It will compare two arms based on freedom from major amputation, freedom from clinically driven target lesion revascularisation (CD-TLR), and primary patency over 12 months.
AMBITION BTK co-principal investigator Ehrin Armstrong said: “Treatment options for below-the-knee lesions are still limited and often depend heavily on balloon angioplasty.
“The Auryon laser can restore laminar flow and therefore has the potential to improve outcomes in this challenging patient population significantly.”
In addition, a companion registry will include up to 1,500 patients who are ineligible for the RCT, who will be treated with the Auryon System for lesions above or below the knee.
The first patient was treated by Anahita Dua, a vascular surgeon at Massachusetts General Hospital and associate professor at Harvard Medical School.
Dr Anahita Dua said: “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.
“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 Atherectomy System, known for treating all infrainguinal lesion types, including above-the-knee and in-stent restenosis, has been used in over 100,000 cases globally.
The Auryon Atherectomy System employs innovative solid-state laser technology to treat peripheral artery disease (PAD).
It is approved by the US Food and Drug Administration (FDA) for infrainguinal stenoses and occlusions, offering minimal vessel wall impact, treating various lesion types and lengths.
The Auryon System’s advanced laser platform, operating at a 355nm wavelength, enables the delivery of short UV laser pulses.
The technology minimises perforation risks and preserves the ability to vaporise lesions without thermal ablation, enhancing treatment outcomes for patients with CLI.
AngioDynamics cardiovascular and international senior vice president/general manager Laura Piccinini said: “The enrolment of the first patient in the AMBITION BTK trial is a significant milestone in our commitment to advancing clinical evidence for the treatment of below-the-knee peripheral artery disease (PAD).
“There is a pressing need for new treatment strategies to help patients suffering from chronic limb ischemia, and we are proud to partner with clinicians to evaluate the Auryon System in this important setting.”
