What question did this study set out to answer?

The aim is to evaluate the safety and effectiveness of the SonyCracker™ intravascular lithotripsy system for treating severely calcified coronary lesions.

January 10, 2026BMC Cardiovascular Disorders0 citationsOpen Access

Efficacy and safety of the SonyCracker™ intravascular lithotripsy device for severely calcified coronary lesions: the LEAD-FIM study from China

HLHaiwei LiuGeneral Hospital of Shenyang Military Region JXJiancheng XiuNanfang Hospital QQQin QinTianjin Chest Hospital

Key Result

The SonyCracker™ IVL device achieved procedural success in 96.7% of patients with severely calcified lesions, exceeding the 85% performance goal (p < 0.001).

Key Points

The aim is to evaluate the safety and effectiveness of the SonyCracker™ intravascular lithotripsy system for treating severely calcified coronary lesions.
Prospective, multicenter, single-arm trial conducted in China.
Enrolled 184 patients with severely calcified coronary lesions requiring PCI.
Primary endpoint assessed was procedural success defined as residual stenosis ≤ 30% and absence of major adverse cardiac events (MACE).
Subgroup analysis using optical coherence tomography (OCT) to assess calcification morphology pre and post-IVL.
Achieved procedural success in 96.7% of patients, surpassing the performance goal of 85% (p < 0.001).
In-hospital MACE events occurred in 3.3% of patients.
30-day and 180-day MACE rates were 3.8% and 4.9%, respectively.
Mean increase in minimum lumen area after IVL was 1.22 ± 0.87 mm², with additional increase post-stenting.
No serious adverse events associated with the device were reported.

Structured PICO

Does a novel intravascular lithotripsy (IVL) system safely and effectively achieve procedural success in patients with severely calcified coronary lesions undergoing PCI?

Population

184 patients aged 18 to 80 years with severely calcified de novo coronary artery lesions (diameter stenosis ≥70% or ≥50% with evidence of ischemia) and a clinical indication for PCI, mean age 61.1, 65.2% male, from China. Key exclusions: planned atherectomy or modified balloon treatment, NYHA class III or IV, LVEF <35%, unprotected left main lesion, or prior stent within 10 mm.

Intervention

Intravascular lithotripsy (IVL) using a novel coronary IVL system (SoniCracker) for vessel preparation prior to drug-eluting stent (DES) implantation.

Outcome

Procedural success, defined as residual stenosis ≤ 30% following successful stent placement and the absence of major adverse cardiac event (MACE, including cardiac death, myocardial infarction, or target vessel revascularization) up to 7 days post-procedure.composite

The novel SoniCracker intravascular lithotripsy system is safe and highly effective for lesion preparation in severely calcified coronary arteries prior to stenting, achieving a 96.7% procedural success rate.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

Calcified lesions represent a key challenge in percutaneous coronary intervention (PCI). In recent years, intravascular lithotripsy (IVL) has emerged as a safe and effective adjunctive therapy for severely calcified lesions before stenting implantation. In the present study, we investigated the safety and efficacy of a novel coronary IVL system in patients with severely calcified lesions. The LEAD-FIM study was a prospective, multicenter, single-arm trial in China. Patients with severely calcified lesions and a clinical indication for PCI with vessel preparation for DES implantation using IVL. The primary endpoint was procedural success, which was defined as residual stenosis ≤ 30% following successful stent placement and the absence of major adverse cardiac event (MACE, including cardiac death, myocardial infarction, or target vessel revascularization) up to 7 days post-procedure. The primary endpoint assessed against performance goals derived from major published registries on Shockwave IVL. A subgroup analysis using optical coherence tomography was carried out to evaluate the morphology of calcification before and after IVL treatment, as well as post-stent. From February to April 2023, a total of 184 patients with severely calcified lesions at 11 sites were enrolled. The target lesions were predominantly in the left anterior descending artery (77.2%) and the mean diameter stenosis was 87.6%±6.6%. Procedure success was observed in 96.7% (178/184) of patients (95%CI: 94.2%-99.3%), which significantly surpassed the prespecified performance goal of 85.0% ( p < 0.001). All patients met the criteria of angiographic success and 6 (3.3%) patients occurred in-hospital MACE event. The rate of 30-day and 180-day MACE was 3.8% (7/184) and 4.9% (9/184), respectively. In the OCT sub-study population, minimum lumen area increased after IVL by 1.22 ± 0.87 mm² and by an additional 2.54 ± 1.73 mm² post stenting with overall stent expansion of 85.3 ± 17.1% at the site of maximal calcification. No serious adverse events associated with the device were documented. The rates of target lesion failure at 1- and 6-month were 3.3% and 4.4%, respectively. The novel IVL system could promote stent delivery and achieve optimized stent expansion among patients with severely calcified coronary lesions. This trial was registered in the clinicaltrials.gov (URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05649488) on 28th November 2022.

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