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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 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

190

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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
Procedimento: 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 Ativo: 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
Procedimento: 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.

O que o estudo está medindo?

Medidas de resultados primários

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

Outras medidas de resultado

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Second Affiliated Hospital, Zhejiang University, School of Medicine

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

30 de setembro de 2029

Conclusão do estudo (Estimado)

30 de junho de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

15 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de agosto de 2026

Primeira postagem (Real)

6 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de agosto de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2026-0688

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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