Comparing Shockwave Intravascular Lithotripsy and OPN Non-Compliant Balloon for Treating Severe Coronary Artery Calcification A Randomized Study on Stent Expansion and Safety in Patients with Calcified Coronary Lesions

What this Trial Is About

Researchers are evaluating treatment strategies for patients with acute and chronic coronary artery disease who have severely calcified coronary lesions. These lesions, found in about 10-20% of patients needing revascularization, pose challenges such as higher risks of target lesion failure and stent thrombosis. The study compares two devices used for preparing these calcified lesions before stent placement the super high-pressure OPN17 NC PCI balloon and the Shockwave intravascular lithotripsy IVL balloon catheter. Participants with heavily calcified coronary lesions will be randomly assigned to have their lesions prepared using either the Shockwave IVL catheter or the OPN17 NC balloon. Initial lesion preparation with smaller balloons or rotablation is allowed if needed. After lesion preparation, all patients will receive a latest-generation drug-eluting stent to treat the lesion. The treatment will be guided by intravascular imaging using optical coherence tomography OCT. Throughout the study, participants will be monitored at the time of the procedure and will have follow-up visits at 30 days, 1 year, and 2 years after treatment. Researchers will assess the final stent expansion using OCT during the procedure and evaluate procedural and strategy success. Safety and effectiveness of each lesion preparation method will be closely observed during these visits.

The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial