MY IVL Study: Calcium modification in complex coronary lesions using LithiX IVL.
The MY-IVL study was an investigator initiated post market study designed to evaluate the safety and performance of intravascular lithotripsy (IVL) for the treatment of calcified, stenotic coronary lesions prior to percutaneous coronary intervention (PCI). As an “all comers” study, it was conducted under conditions of routine clinical practice and included a complex patient population with diverse calcium morphologies.
- A total of 102 consecutive patients were treated with IVL.
- Enrollment took place at Cardiac Vascular Sentral Kuala Lumpur (CVSKL) Hospital between April and September 2025.
- All patients underwent angiography, and 100% received intravascular imaging (IVUS/OCT).
- All imaging data were analyzed by an independent core laboratory (MedStar Health).
Primary safety endpoint: Freedom from MACE* within 30 days after the index procedure.
Co-primary efficacy endpoint 1: Proportion of patients achieving residual stenosis under 30%, including both stent and drug-coated balloon (DCB) treatment, without intraprocedural MACE.
Weighted co-primary efficacy endpoint 2: Minimal stent area (MSA) compared with a performance goal (PG**) of at least 4.9 mm², assessed by intravascular imaging (stent cohort only).
Follow-up was performed at 30 days.
* MACE is defined as a composite of cardiovascular death, myocardial infarction, and target vessel revascularization.
** The performance goal (PG) was derived from the mean MSA (5.65 mm²) reported in previous IVL and rotational atherectomy studies, with a statistical safety margin of 0.75 mm².
§ Unstable angina, STEMI, or NSTEMI.
‡ Stable angina or silent ischemia.
The results of the MY-IVL study demonstrated effective and safe fragmentation of a wide range of severely calcified lesion morphologies in a complex all-comers patient population.
| Calcium Eccentricity | Eccentric Calcium | Concentric Calcium | Overall | |
|---|---|---|---|---|
| Mean stent expansion‡, % | 123.15 ± 13.81 (L=13) | 106.77 ± 18.30 (L=13) | 110.96 ± 17.97 (L=27) | |
| Maximum continuous calcium arc, ° | ≤180° | >180° and ≤270° | >270° and ≤360° | 113.71 ± 17.80 (L=58) |
Of the 58 lesions with mean stent expansion, 53 had baseline calcium arc available. Imaging Core Lab adjudicated.
| Final Post-PCI | L=116 |
|---|---|
| Acute gain, mm | 1.75 ± 0.58 |
| Minimum lumen diameter, mm | 2.65 ± 0.56 |
| In-lesion DS, % | 10.71 ± 11.49 |
| In-lesion DS <50% | 116 (100.0%) |
| In-lesion DS <30% | 109 (94.0%) |
Imaging Core Lab adjudicated.
- No angiographic complications related to the IVL device*
- Freedom from MACE (30 days): 98 (96.1%)**
* One patient experienced a perforation during stent implantation, not related to IVL.
** No device-related events were reported. Three cardiovascular deaths were adjudicated by the study site as unrelated to the IVL procedure, and the cause of death was unknown in one case.
Minimal stent area‡ (MSA) of the stented lesion after IVL, statistically evaluated against the performance goal.
[1] Muthusamy TS, et al. Hertz contact intravascular lithotripsy for calcified coronary lesions in real-world practice: Primary outcomes of the MY-IVL post-market study. Cardiovasc Revasc Med. 2026. Study results (PDF)