AngioDynamics招募首例患者参与AMBITION膝下随机研究

Trial Investigates Use of Auryon Atherectomy System in Cases with Challenging Below-the-Knee Blockages

AngioDynamics, Inc. (NASDAQ:ANGO), a medical technology company focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options and improving patient quality of life, today announced enrollment of the first patient in the Randomized Study of the Auryon Atherectomy System Used in Combination with Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone Treating Infrapopliteal Lesions in Subjects with Critical Limb Ischemia Below-the-Knee (AMBITION BTK).

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 Critical Limb Ischemia (CLI). 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.