AngioDynamics has enrolled the first patient in its AMBITION BTK study, evaluating the Auryon atherectomy system for treating below-the-knee critical limb ischemia. The trial pairs Auryon with standard balloon angioplasty and compares outcomes to angioplasty alone in patients with infrapopliteal lesions.
The study’s primary endpoint uses a win-ratio approach, factoring in freedom from major amputation, target lesion revascularization, and vessel patency at 12 months. Up to 224 patients will be enrolled across 30 sites, alongside a 1,500-patient registry for those ineligible for the trial.
The first patient was treated at Massachusetts General Hospital by vascular surgeon Dr. Anahita Dua, who emphasized the importance of gathering high-quality real-world data to assess laser-based treatment approaches in this challenging patient population.
Auryon’s solid-state laser technology offers versatility in treating lesions of any type or length with minimal vessel trauma. AngioDynamics says this could mark a pivotal advancement in treating peripheral artery disease, particularly below the knee.
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