First-in-Human Study of AVS Pulse Intravascular Lithotripsy System to Open Calcified Coronary Artery Vessels and Improve Vascular Flexibility for Coronary Artery Disease

What this Trial Is About

Researchers are evaluating the safety and early effectiveness of the AVS Pulse Intravascular Lithotripsy Pulse IVL System for treating coronary artery disease. This first-in-human, open-label study will include up to fifteen patients with severely calcified coronary arteries. The study aims to assess how well the device opens vessels with calcific walls and enhances vascular compliance and remodeling. Participants will receive treatment using the Pulse IVL System to prepare severely calcified coronary arteries before stenting. The study focuses on treating single new coronary lesions in arteries such as the left anterior descending, right coronary, left circumflex, or ramus intermedius. The treatment involves using the device to break down calcifications to allow stent placement. This study has no placebo or comparator group, and all participants receive the investigational device. During the study, participants will be closely monitored for residual narrowing of the artery after treatment and stenting, aiming for less than 50% stenosis. Researchers will also track any major device-related adverse events and target lesion failure within 30 days of the procedure. Participants will undergo assessments including imaging and clinical evaluations to measure safety and effectiveness. The study is expected to continue through December 2027, with detailed follow-up after the procedure.

AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease