POWER PAD 2 Trial is a study to test the safety and effectiveness of a medical device called the Pulse Intravascular Lithotripsy (Pulse IVL) System. This device helps treat certain arteries in the leg that have become very narrow and hard due to a buildup of calcium, which is known as calcification. The study focuses on the superficial femoral and popliteal arteries, which are in the thigh and knee area. The participants must be over 18 years old and have a medical condition called peripheral arterial disease (PAD), which affects blood flow in the legs.
The study will involve up to 120 participants at 20 different locations in the U.S. Participants will have check-ups right after the procedure, then again at 30 days and 6 months later. Some important things for participants to consider:
- The study lasts for about 6 months with several follow-up visits.
- Participation involves a medical procedure on the leg arteries.
- There may be risks, such as complications from the procedure, which will be explained by the study team.
Participants must not have any severe infections, recent surgeries, or be pregnant. They should also not have any other serious health problems that could interfere with the study.