This study is looking at how well a device called the Shockwave C2 Aero Coronary IVL System works for people with coronary artery disease (CAD), specifically when there's a lot of calcium buildup in their heart arteries. This device uses intravascular lithotripsy (IVL), which is like tiny sound waves, to help prepare the artery before a stent is placed. You might be able to join if you are at least 18 years old, are having a procedure called PCI (percutaneous coronary intervention) for CAD, and your doctor plans to use IVL and a stent. The study will look at how successful the procedure is and if there are any problems with the treated artery within 30 days. The study aims to enroll up to 200 people.

Study design

This is a single-arm study, meaning everyone receives the same treatment, and it will enroll up to 200 participants. It is an interventional study, but the phase is not specified.

What's involved

You would undergo PCI with the Shockwave C2 Aero system and stent placement as part of your standard care. You would need to comply with study follow-up requirements.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed through hospital discharge, then at 30 days, and again at 1 year after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.