A Study to Evaluate the Safety and Effectiveness of the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System in Adults With Peripheral Artery Disease (PAD)

The purpose of this clinical study is to learn if the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System is safe and works well to help people with peripheral artery disease (PAD) who have hard, calcium-filled blockages in their leg arteries. The study will test the idea that using sound waves inside the artery can safely break up calcium and make it easier to open the artery so blood can flow better. The main question this study is trying to answer is: Can treatment with the FastWave Artero™ IVL System safely widen blocked leg arteries and lower the chance of serious problems during or after the procedure? About 110 adults at up to 30 medical centers in the United States will take part. Everyone in the study will receive the IVL treatment. During the study, participants will: Have a minimally invasive procedure using the FastWave IVL System Stay for a short observation period after the procedure Return for follow-up visits about 30 days and 6 months later Researchers will look at how well the arteries open, how long they stay open, and whether any major complications occur. The results will help determine if the FastWave Artero™ IVL System can be used as a safe and effective treatment for people with PAD and severe calcium buildup in the leg arteries.

NCT Number	NCT07209085
Lead Sponsor	FastWave Medical Collaborators: Rede Optimus Hospitalar SA, Medical Metrics Diagnostics, Inc
Conditions	Peripheral Artery Disease (PAD)
Enrollment	110 participants
Start Date	2025-12
Primary Completion	2026-09 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2025-10-09