The FORWARD CAD IDE Study tests a new treatment for tight, hard blockages in heart arteries. These blockages are called calcified coronary lesions. The study uses the Shockwave Intravascular Lithotripsy (IVL) System and the Javelin Coronary IVL Catheter. The goal is to make these blockages easier to treat by softening the calcium in the arteries.
Participants will be adults with heart disease, either with stable chest pain (angina) or who have stabilized after a heart attack. Up to 158 people will be part of the main group, and up to 250 more can join an additional group. The study takes place at 35 different locations.
- Participants must be willing to attend all study assessments.
- Participants must have specific types of heart artery blockages suitable for the procedure.
- Women must not be pregnant or nursing.
This study involves a medical procedure, so it's important to discuss with a doctor if you are eligible and consider any potential risks or benefits before joining.