Peripheral Arterial Disease Clinical Trial
Official title:
PATHFINDER I: Post-Market Registry of AURYON™ Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease (PATHFINDER-Registry, EX-PAD-05)
The PATHFINDER I Registry is a prospective, non-randomized, single arm, multicenter observational study. It is a pilot registry study towards a subsequent large pivotal phase registry. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term) of the AURYON™ Atherectomy System, within the initial launch phase of the product in the market.
US multicenter, prospective, single-arm, observational post market Registry. A pilot registry towards a subsequent large pivotal registry (PATHFINDER II), aimed to evaluate the safety and efficacy of Auryon™ Atherectomy System in the treatment of de novo, re-stenotic and ISR lesions in infra-inguinal arteries of Peripheral Artery Diseases (PAD) subjects, in a real-world setting within the initial launch phase of the product in the market. ;
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