The Shockwave Coronary Intravascular Lithotripsy (IVL) system is being studied to see if it's safe and effective for treating blocked heart arteries that have a lot of calcium. This system uses a special catheter, which is a thin tube, that sends sound waves to soften the calcium in the artery, making it easier to place a stent. A stent is a small tube that helps keep the artery open. The study will include up to 145 people with a specific heart condition called calcified stenosis, which means their arteries are narrowed and have calcium buildup.
- The study lasts about 2 years, with follow-ups at 30 days, 6 months, and 12 months.
- It takes place at up to 20 different locations in the US.
- Participants must be at least 18 years old and meet specific health criteria.
Those interested should know they will be closely monitored and will need to visit the study site several times. Participants will be selected based on their health condition, and not everyone will qualify. Always discuss with your doctor before joining any study to understand the risks and benefits.