The FORWARD CAD IDE Study is a research study examining a new device called the Shockwave Intravascular Lithotripsy (IVL) System. This study aims to see if the device is safe and effective for treating narrowed heart arteries that have hardened due to calcium buildup before placing a stent. The Intravascular Lithotripsy uses sound waves to break up the calcium in the arteries, making it easier for doctors to treat the blockage.
The study plans to include up to 158 people with certain types of heart conditions from 35 different sites. Participants should be 18 years or older and agree to all study requirements. They may have heart artery disease but should not have had a recent heart attack or other serious conditions like kidney disease or uncontrolled high blood pressure.
- The study involves multiple visits across different sites and is non-emergent, meaning it is planned and not a rush procedure.
- Participants must be willing to undergo various assessments and follow-up visits.
- There are strict criteria for both inclusion and exclusion, ensuring participants' safety and data accuracy.