Shockwave C2 Aero for Coronary Artery Disease

(AERO CAD Trial)

This trial tests a new device, the Shockwave C2 Aero Coronary IVL System, for individuals with coronary artery disease, characterized by hardened arteries in the heart. The trial aims to assess how effectively this device opens blocked arteries and evaluates patient outcomes 30 days post-treatment. Individuals who have undergone a heart procedure called PCI and require further treatment with this device may be suitable candidates. The trial seeks to gather real-world data on the device's effectiveness and success in these procedures. As an unphased trial, it provides patients the chance to contribute to valuable real-world data on a potentially groundbreaking treatment.

The trial information does not specify if you need to stop taking your current medications. However, if you have a known contraindication (reason not to use) to antiplatelet or anticoagulation therapy, you cannot participate. It's best to discuss your medications with the study team.

Research has shown that the Shockwave C2 Aero Coronary IVL System is generally safe for people with hardened arteries in the heart. This system treats blocked arteries by safely breaking down calcium deposits. Studies indicate that the procedure has few side effects, with most patients experiencing no major issues during or after treatment. The system is also approved for use, meeting established safety standards.¹²³⁴⁵

Researchers are excited about the Shockwave C2 Aero Coronary IVL System because it offers a novel approach to treating coronary artery disease. Unlike traditional treatments that often involve balloon angioplasty or atherectomy, this system uses intravascular lithotripsy (IVL) to break up calcified plaques in the arteries. This method uses sound waves to safely and effectively fracture hardened plaques, potentially making stent placement easier and more successful. The precision and minimally invasive nature of this technique could lead to better outcomes and fewer complications for patients with complex coronary artery blockages.

Studies have shown that the Shockwave C2 Aero Coronary IVL System effectively treats hardened arteries in the heart. This system uses sound waves to break up calcium deposits in the arteries, aiding doctors in placing a stent (a small tube that keeps the artery open) more easily during procedures. Research indicates that this method is safe because the sound waves specifically target the calcium without affecting the surrounding healthy tissue. Initial findings suggest that this approach improves the procedure's success and can manage difficult artery conditions, making it a promising option for patients with hardened arteries. Participants in this trial will undergo PCI with coronary IVL using the Shockwave C2 Aero system, followed by stent placement.¹⁴⁶⁷⁸