Comparing Super High-pressure Balloon and Intravascular Lithotripsy for Preparing Severe Calcified Coronary Lesions in PCI

What this Trial Is About

Researchers are evaluating different preparation techniques for severely calcified coronary lesions in patients undergoing percutaneous coronary intervention PCI. The trial compares the effects of a super high-pressure balloon and intravascular lithotripsy IVL on stent expansion and safety. Calcified plaques make stent placement challenging and increase the risk of treatment failure, so finding optimal preparation methods is important. Participants receive PCI guided by intravascular imaging using either the super high-pressure balloon or IVL to prepare the calcified lesions before stent implantation. The super high-pressure balloon is a novel device that can expand uniformly under extreme pressure. IVL uses sonic pressure pulses to fracture calcium plaques within the artery. Both methods are being studied to determine their effectiveness and safety in this setting. During the study, stent expansion is measured using intraprocedural imaging techniques such as optical coherence tomography or intravascular ultrasound. Researchers also monitor major adverse cardiac events within 30 days after the procedure. Participants will be assessed throughout the PCI procedure and followed up to evaluate outcomes. The total participation duration includes the procedure and at least a 30-day safety follow-up.

Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions