Study Protocol for the Evaluation of Morphologic and Imaging Remodeling of Atherosclerotic Plaque Following Intravascular Lithotripsy in Peripheral Artery Disease

The primary outcome is the quantitative assessment of changes in plaque morphology and volume within the index target lesion, based on pre- and post-procedural computed tomography angiography using TeraRecon™ (Durham, NC, USA) plaque analysis module, reflecting plaque modification and redistribution, in the context of IVL-based vessel preparation. Secondary outcomes include improvement of peripheral arterial perfusion and freedom from clinically driven target lesion revascularization (CD-TLR) and major adverse events.