The study aims to test the safety and effectiveness of the Golazo® Peripheral Atherectomy System for people with symptoms of peripheral arterial disease (PAD) in their legs. PAD is when arteries in your legs get narrow and reduce blood flow. The study will involve 159 participants across up to 15 sites in the U.S. Participants will have a procedure called an atherectomy, where a device removes plaque from blood vessels, and be followed for 6 months.
- The study lasts for 6 months with follow-up visits.
- Participants need to be at least 18 years old and meet specific health criteria.
- Risks may include complications from the procedure or existing conditions.
To join, you'll need to have an ankle brachial index (ABI) test, which measures blood flow in your legs. You cannot participate if you've had recent surgery or certain health conditions like severe kidney disease or heart issues. It's important to discuss with your doctor if this study is the right choice for you.