Intravascular Lithotripsy Versus Rotational Atherectomy for Severe Coronary Artery Calcification: A Prospective, Multicenter, Non-inferiority Randomized Controlled Trial (LIRAC)

Severely calcified coronary lesions represent one of the major challenges in interventional cardiology. Severe coronary calcification increases the difficulty and complexity of percutaneous coronary intervention (PCI), impedes device delivery, and may even lead to device failure. Moreover, stent underexpansion further elevates the risks of cardiac death, myocardial infarction, target vessel revascularization, and in-stent thrombosis. Rotational atherectomy (RA) is an effective modality for treating severely calcified coronary lesions, as it adequately modifies calcific plaques, facilitates luminal enlargement, and improves device deliverability. However, RA fragments calcific plaques into microparticles that are subsequently cleared by the reticuloendothelial system in the distal microvasculature, potentially inducing microvascular dysfunction.

In recent years, intravascular lithotripsy (IVL) has emerged as an innovative calcium-modification technique in clinical practice. This technology employs acoustic pressure waves to selectively disrupt deep-seated calcific plaques, inducing fractures within the calcium while sparing the soft tissue of the vessel wall from substantial injury. IVL is performed with low-pressure balloon inflation (4-6 atm), which helps to minimize the risk of vascular injury; its mechanism of action does not produce macroscopic debris, theoretically obviating distal embolization and associated microcirculatory disturbances. Recently published prospective observational studies-the REPLICA-EPIC18 and BENELUX-IVL registries-have demonstrated that IVL is feasible and safe in "real-world" severely calcified lesions, effectively facilitating stent implantation.

Although both RA and IVL are important tools for managing severe calcific lesions, there remains a paucity of high-level, head-to-head evidence directly comparing post-procedural minimal stent area between the two modalities. Clarifying this issue is of significant clinical importance for guiding clinicians in selecting optimal revascularization strategies tailored to distinct pathological characteristics and patient profiles, thereby improving procedural safety and patient outcomes. To this end, we plan to conduct a prospective, multicenter, randomized clinical trial (RCT) aimed at comparing the minimal stent area between intravascular lithotripsy and rotational atherectomy in patients with severely calcified lesions.

Study Overview

• Status: Not yet recruiting
• Conditions: Intravascular Lithotripsy; Intravascular Ultrasound; Coronary Artery Calcifications; Rotational Atherectomy
• Intervention / Treatment: Procedure: intravascular lithotripsy; Procedure: rotational atherectomy

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Jiang, MD, PhD; Phone Number: 86-571-8778-3992; Email: jiang-jun@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years;
2. Target lesion with diameter stenosis ≥ 50% (visual estimation) associated with evidence of myocardial ischemia;
3. Target lesion must be a de novo, in-situ severely calcified coronary lesion, where severe calcification is defined as: radiopacity visible prior to contrast injection and in the absence of cardiac pulsation, typically involving both sides of the vessel wall; and ≥270° circumferential calcification as evidenced by intravascular ultrasound (IVUS);
4. Target vessel reference diameter between 2.5 and 4.0 mm, with successful guidewire traversal;
5. A maximum of two non-target lesions requiring interventional treatment, which must be successfully treated prior to the target lesion;
6. Patients presenting with evidence of symptomatic or asymptomatic myocardial ischemia, stable or unstable angina pectoris, or prior myocardial infarction;
7. Signed written informed consent obtained.

Exclusion Criteria:

1. Cardiogenic shock or hemodynamic instability;
2. Chronic total occlusion (CTO);
3. Requirement for intraprocedural mechanical circulatory support, such as intra-aortic balloon pump (IABP) or Impella device;
4. Acute ST-segment elevation myocardial infarction (STEMI) occurring within 1 month prior to enrollment;
5. Angiographically visible thrombus at the target lesion site;
6. Left main ostial lesion with stenosis ≥ 50%;
7. Left ventricular ejection fraction (LVEF) < 40%;
8. New-onset stroke or transient ischemic attack (TIA) within 90 days;
9. Bypass graft lesion;
10. Coronary artery dissection of type B or greater (NHLBI classification);
11. Pregnant or lactating patients;
12. Life expectancy < 1 year;
13. Active bleeding;
14. Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m²;
15. Presence of cognitive or psychiatric disorders, as confirmed by clinical diagnosis or investigator assessment;
16. Illiteracy, semi-literacy, or any visual impairment, reading/writing disability that prevents the patient from independently reading the patient information sheet and personally providing written informed consent without assistance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravascular lithotripsy group; IVL:Intravascular lithotripsy (IVL) balloon is used to dilate severely calcified plaques. Pre-dilatation with a balloon ≤2.0 mm is permitted. Intravascular ultrasound (IVUS) with automated pullback must be performed both after lithotripsy and at the end of the procedure	Procedure: intravascular lithotripsy; The procedure entails the use of a lithotripsy balloon for dilation of severely calcified plaques. Pre-dilatation may be performed with a balloon up to 2.0 mm in diameter. Intravascular ultrasound (IVUS) with automated pullback is mandatory immediately following lithotripsy and upon completion of the procedur
Active Comparator: Rotational atherectomy group; RA:The procedure involves using a rotational atherectomy burr to modify severely calcified plaques. After the burr has traversed the lesion, three to five additional polishing runs are required to achieve optimal plaque modification. If 1:1 balloon dilatation at the target lesion is performed with satisfactory expansion, rotational atherectomy is terminated. Intravascular ultrasound (IVUS) with automatic pullback must be performed both immediately after rotational atherectomy and at the end of the procedure	Procedure: rotational atherectomy; The procedure involves using a rotational atherectomy burr to modify severely calcified plaques. After the burr has traversed the lesion, three to five additional polishing runs are required to achieve optimal plaque modification. If 1:1 balloon dilatation at the target lesion is performed with satisfactory expansion, rotational atherectomy is terminated. Intravascular ultrasound (IVUS) with automatic pullback must be performed both immediately after rotational atherectomy and at the end of the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
minimal stent area	Within one hour post-percutaneous coronary intervention

Other Outcome Measures

Outcome Measure	Time Frame
target vessel failure	1 year
major adverse cardiac event	1 year
success rate of PCI	Within one hour post-percutaneous coronary intervention
complications during perioperative period	during perioperative period
IVUS image feature analysis	Within one hour post-percutaneous coronary intervention
TnT+CK/CKMB	24 hours post-PCI
The dosage of contrast agent, the amount of X-rays exposed and the operation time	during the PCI
Subgroup analysis of gender, age, diabetes, etc	1 year
The differences and influences of computational physiology and microcirculation between the two groups of patients	1 year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: August 3, 2026
• First Posted (Actual): August 6, 2026

Study Record Updates

• Last Update Posted (Actual): August 6, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Angioplasty; Catheterization; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Atherectomy; Myocardial Revascularization; Cardiac Surgical Procedures; Percutaneous Coronary Intervention; Thoracic Surgical Procedures; Atherectomy, Coronary
• Other Study ID Numbers: 2026-0688

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No