Comparing Intravascular Lithotripsy and Balloons for Treating Resistant Stent Under-Expansion in Coronary Artery Disease

What this Trial Is About

Researchers are investigating the best way to treat in-stent restenosis ISR caused by stent under-expansion UE, which occurs in 5-10% of patients undergoing percutaneous coronary intervention PCI. ISR can result from mechanical issues like under-expansion, neointimal hyperplasia, or neoatherosclerosis. Current guidelines recommend using non-compliant and very-high-pressure balloons, but these often lead to less than ideal results. This trial compares intravascular lithotripsy IVL with balloon treatments in patients with ISR and UE to evaluate which approach is more effective and safe. The study randomly assigns patients to one of two treatments one group receives IVL to treat ISR with UE, while the other group is treated with non-compliant balloons, very high-pressure balloons, or cutting balloons. IVL is a newer method suggested to safely address calcified lesions causing stent under-expansion, while balloon treatments are standard but may be less effective. The trial will carefully monitor the treatment delivery and success during the procedure and follow patients for up to 36 months. Participants will undergo coronary angiography and optical coherence tomography OCT imaging to assess stent expansion and lesion characteristics. Researchers will measure the stent expansion immediately after PCI and track clinical events such as procedural success, complications, and safety outcomes during the first week and throughout the 36-month follow-up. The study includes detailed evaluations of minimal stent area, success of device delivery, and any adverse events to understand the long-term effectiveness and safety of the treatments.

Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions