The study tests the Golazo® Peripheral Atherectomy System for treating Peripheral Arterial Disease (PAD), which is when blood vessels in the legs get narrow, causing pain. The study will include 159 people in the U.S. who will use this system to remove blockages in their leg arteries. An "atherectomy" is a procedure that removes plaque (fatty deposits) from blood vessels to improve blood flow. Participants will be monitored for 6 months after the procedure to check safety and effectiveness.
To join, you must be 18 or older, have a life expectancy over a year, and be suitable for this procedure. You should not have recent surgeries, infections, or severe heart/kidney issues. Pregnant women cannot participate. The study is "open-label," meaning everyone knows the treatment being given.
- The study lasts 6 months after the procedure.
- You must visit one of the 15 U.S. sites for the procedure and follow-up.
- All participants must comply with study procedures and assessments.