AngioDynamics has enrolled the first subject in the AMBITION BTK trial, which aims to assess the Auryon atherectomy system when used in conjunction with standard balloon angioplasty, against balloon angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia (CLI).
The primary endpoint of the multi-centre, prospective, randomised controlled trial (RCT) will be assessed utilising a win-ratio method at 12 months. There will also be a focus on freedom from major amputation or clinically driven target lesion revascularisation (CD-TLR), and primary patency.
The trial will involve up to 224 subjects at up to 30 centres.
Simultaneously, a companion registry is set to enrol up to another 1,500 subjects who do not qualify for the RCT and are treated with the Auryon system for lesions above or below the knee.
Massachusetts General Hospital vascular surgeon and Harvard Medical School associate professor of surgery Anahita Dua, who is also AMBITION BTK鈥檚 co-principal investigator, treated the first subject in the trial.
AngioDynamics’s cardiovascular and international senior vice-president/general manager Laura Piccinini said: 鈥淭he 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).
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By GlobalData鈥淭here 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.鈥�
According to the company, Auryon is the first laser atherectomy system designed for treating any lesion type, length and location with less impact on vessel walls.
Leveraging solid-state laser technology to treat PAD, it is cleared by the US Food and Drug Administration (FDA) to treat infrainguinal stenoses and occlusions, including in-stent restenosis (ISR).
The system’s targeted biological reactions claim to reduce the perforation risk and maintain the ability to vaporise lesions with no thermal ablation.
Its 355nm wavelength laser platform allows for the use of longer wavelengths and shorter pulse durations, delivering short ultraviolet (UV) laser pulses.
Last year, AngioDynamics collaborated with the UK鈥檚 University College London Hospital to initiate a prospective registry study to assess the long-term effects of the NanoKnife system for treating unifocal intermediate-risk prostate cancer.
