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

3 de agosto de 2026 actualizado por: Second Affiliated Hospital, Zhejiang University, School of Medicine

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

190

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Jun Jiang, MD, PhD
  • Número de teléfono: 86-571-8778-3992
  • Correo electrónico: jiang-jun@zju.edu.cn

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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
Procedimiento: 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
Comparador activo: 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
Procedimiento: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
minimal stent area
Periodo de tiempo: Within one hour post-percutaneous coronary intervention
Within one hour post-percutaneous coronary intervention

Otras medidas de resultado

Medida de resultado
Periodo de tiempo
falla del vaso objetivo
Periodo de tiempo: 1 año
1 año
major adverse cardiac event
Periodo de tiempo: 1 year
1 year
success rate of PCI
Periodo de tiempo: Within one hour post-percutaneous coronary intervention
Within one hour post-percutaneous coronary intervention
complications during perioperative period
Periodo de tiempo: during perioperative period
during perioperative period
IVUS image feature analysis
Periodo de tiempo: Within one hour post-percutaneous coronary intervention
Within one hour post-percutaneous coronary intervention
TnT+CK/CKMB
Periodo de tiempo: 24 hours post-PCI
24 hours post-PCI
The dosage of contrast agent, the amount of X-rays exposed and the operation time
Periodo de tiempo: during the PCI
during the PCI
Subgroup analysis of gender, age, diabetes, etc
Periodo de tiempo: 1 year
1 year
The differences and influences of computational physiology and microcirculation between the two groups of patients
Periodo de tiempo: 1 year
1 year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Second Affiliated Hospital, Zhejiang University, School of Medicine

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

30 de septiembre de 2029

Finalización del estudio (Estimado)

30 de junio de 2030

Fechas de registro del estudio

Enviado por primera vez

15 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de agosto de 2026

Publicado por primera vez (Actual)

6 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de agosto de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2026-0688

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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