Safety and Efficacy of Intravascular Lithotripsy System: A Prospective, Multicenter Clinical Trial (The VIGOUR Study).

Abstract

Background: Optimal plaque preparation in calcified coronary lesions is essential to prevent stent failure. Intravascular lithotripsy (IVL) has shown safety and efficacy in treating severe coronary calcification in prior studies. This study aimed to assess the safety and effectiveness of IVL using domestically produced balloons for the treatment of calcified de novo coronary lesions in Chinese patients.

Methods: The VIGOUR trial (NCT05818098) was a prospective, multicenter, single-arm study designed to obtain approval for coronary IVL in patients with severe coronary calcification. The primary endpoint was procedural success. Secondary endpoints included device success, angiographic success, 30-day major adverse cardiovascular events (MACE) incidence, and procedure-related serious complications. An optical coherence tomography (OCT) sub-study was conducted to assess the mechanisms and predictors of calcium modification.

Results: A total of 189 patients were enrolled. The primary endpoint was achieved in 93.7% of cases, exceeding the performance goal of 87.0% (p < 0.001). At the secondary endpoints, device success was achieved in 98.9% of patients, and angiographic success in 98.4%. The 30-day MACE incidence was 5.3%, and procedure-related serious complication was 0.5%. 81.9% (59/72) of lesions exhibited OCT-identified multi-plane and longitudinal calcium fractures after IVL. Multivariable analysis revealed that calcium angle was associated with OCT-identified calcium fractures.

Conclusions: IVL using domestically produced balloons significantly improves vessel compliance, facilitating successful stent delivery and deployment. This approach proves to be both effective and safe in the Chinese population with severely calcified coronary arteries. OCT-identified calcium fractures post-IVL are more likely in calcified lesions with a larger calcium angle.