Evaluating the Safety and Effectiveness of the Golazo4 Peripheral Atherectomy System for Treating Peripheral Arterial Disease in the Lower Limbs

What this Trial Is About

Researchers are evaluating the Golazo4 Peripheral Atherectomy System in people with symptomatic infrainguinal peripheral arterial disease PAD. This prospective, multicenter, single-arm study aims to provide reasonable assurance of the safety and effectiveness of this device when used as intended. It involves up to 159 participants across multiple investigational sites in the U.S. who have PAD affecting their lower limbs. Participants will receive atherectomy treatment using the Golazo4 Peripheral Atherectomy System, a sterile, single-use percutaneous device designed for removing plaque from peripheral blood vessels. After treatment, participants will be followed and assessed for up to 6 months to monitor outcomes. The study focuses on safety and technical success during the procedure and tracks clinical success and adverse events during follow-up. Throughout the trial, participants will undergo assessments of blood flow, limb function, and complications related to the procedure. Researchers will measure freedom from major adverse events within 30 days, technical success during surgery, and longer-term outcomes such as vessel patency and limb health over 6 months. Participants progress will be monitored through clinical visits and evaluations to understand the treatments impact and safety.

The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)