A Novel Intravascular Piezoelectric Wire System in Coronary Chronic Total Occlusions Recanalization: Preclinical and First-in-human Outcome

Background and purpose: Percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) remains challenging, with lower success rates compared to non-CTO procedures, particularly in the presence of calcified or fibrotic lesions. This study evaluates a novel intravascular piezoelectric wire system (IPWS) designed to facilitate guidewire advancement through these difficult CTO. Methods: We conducted a two-phase investigation: a preclinical feasibility and safety study in a porcine model, followed by a first-in-human clinical trial. The IPWS consists of a shockwave generator and a disposable guidewire that delivers high-amplitude mechanical pulses to facilitate penetration through calcified or fibrotic lesions. In the clinical phase, the system was used in 10 patients with CTO where standard antegrade wire escalation had failed. Results: In the preclinical study, the IPWS demonstrated excellent device compatibility with microcatheters and showed no significant vascular injury or thrombosis on histology. In the clinical trial, the IPWS achieved a 90% procedural success rate, successfully recanalizing nine of 10 CTO. No major adverse cardiac events (MACE) occurred during the 30-day follow-up. Mild complications, such as slow blood flow and marginal branch involvement, were transient and resolved without further intervention. Conclusions: The IPWS is a safe and feasible technology that may improve the success rate in complex CTO PCI. By facilitating wire passage through challenging lesions, the IPWS could reduce procedural complexity and risk. Further refinements are warranted, but this technology holds significant promise for advancing the treatment of CTO and other complex vascular interventions.