Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions: an Investigator-initiated, Open-label, Multicentre, Randomised, Superiority Trial
Percutaneous coronary intervention (PCI) encounters challenges with calcified coronary lesions, leading to potential issues such as failed balloon dilatation, incomplete stent expansion, and increased risks of adverse events post-PCI, including stent restenosis and thrombosis. Intravascular lithotripsy (IVL), a novel approach for severely calcified coronary lesion preparation, has shown promising preliminary outcomes. Combining IVL with conventional approaches, such as Rotational atherectomy (RA), non-compliant balloons, or cutting balloons, may associated with additional benefit than conventional approaches only in terms of better stent expansion and lower long-term adverse events. This pilot randomized trial aims to investigate whether combining IVL to conventional therapy surpasses the efficacy of conventional approaches alone. The primary effectiveness endpoint is final stent expansion assessed by post-procedure optical coherence tomography (OCT), and the primary safety endpoint is target lesion failure (TVF). The trial seeks to provide valuable insights into the optimal approach for managing severely calcified coronary lesions during PCI.
• Patients with acute or chronic coronary artery syndrome indicated for PCI with stenting.
• Able to understand and provide informed consent and comply with all study procedures
∙ Angiographic Inclusion Criteria:
• Native and de novo coronary artery disease
• Lesion navigable by a 0.014 guidewire.
• Target lesion is severely calcified, meeting one of the following criteria:
‣ Presence of calcium ≥ 270°, lengths ≥ 5mm, and thickness ≥ 0.5mm at one cross-section as assessed by OCT
⁃ If the OCT catheter is unable to pass through the target lesion after dilatation due to calcification or tortuosity, and the target lesion is severely calcified on both sides of the arterial wall during angiography, with the length of the calcification \>15 mm, the lesion will be recognized as a severely calcified lesion, meeting the criteria for enrollment