Intravascular Lithotripsy for Coronary Artery Disease

(NODULE-SHOCK Trial)

This trial tests a new method for treating coronary artery disease, a condition where the arteries supplying blood to the heart become narrow or blocked. The trial compares intravascular lithotripsy (IVL), which uses sound waves to break up calcium deposits in arteries, with or without an additional step called rotational atherectomy (RA) for patients with specific types of calcium build-up. Patients with narrowed heart arteries and moderate to severe calcium build-up who plan to receive a stent might be suitable for this trial. As an unphased study, this trial provides a unique opportunity to explore innovative treatment options for coronary artery disease.

The trial information does not specify if you need to stop taking your current medications. However, if you have an allergy or cannot take certain blood thinners like aspirin or clopidogrel, you may not be eligible to participate.

Research has shown that intravascular lithotripsy (IVL) is generally safe for treating hardened areas in heart arteries. Studies have found that IVL aids in placing stents in these challenging spots without major safety concerns. Strong evidence from several studies indicates that IVL is well-tolerated and effective for patients with severe calcium buildup in their arteries.

For rotational atherectomy (RA), evidence suggests it is also safe for treating hardened nodules in heart arteries. Various studies have demonstrated its success in these procedures with few complications. However, issues like slow or no blood flow can occur during or after the procedure, but these are usually managed effectively.

Intravascular lithotripsy (IVL) is unique because it offers a new way to tackle coronary artery disease by using sound waves to break up calcium deposits in the arteries. Unlike traditional methods like balloon angioplasty or rotational atherectomy, IVL aims to safely fracture calcium without damaging surrounding artery walls. Researchers are excited because this technique could make stent placement smoother and potentially reduce complications associated with coronary intervention. Plus, the precision of IVL might allow for more tailored treatments, whether using maximum pulses or operator-determined levels, offering flexibility in managing severe coronary calcifications.

This trial will compare different approaches to treating coronary artery disease using intravascular lithotripsy (IVL) and rotational atherectomy (RA). Studies have shown that IVL effectively treats very hard calcium build-up in heart arteries, facilitating safer stent placement. Research indicates that IVL significantly improves artery size and reduces blockages, achieving success rates similar to other modern treatments. In this trial, some participants will receive IVL alone, while others will receive a combination of RA followed by IVL for specific types of calcium build-up, such as coronary calcified nodules. RA effectively clears heavily calcified areas, improving blood flow. Together, these treatments show promise in addressing complex heart conditions by breaking up hard calcium deposits in arteries.²³⁵⁶⁷