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

3. august 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

190

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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
Aktiv komparator: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
minimal stent area
Tidsramme: Within one hour post-percutaneous coronary intervention
Within one hour post-percutaneous coronary intervention

Andre resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

30. september 2029

Studieafslutning (Anslået)

30. juni 2030

Datoer for studieregistrering

Først indsendt

15. juli 2026

Først indsendt, der opfyldte QC-kriterier

3. august 2026

Først opslået (Faktiske)

6. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. august 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-0688

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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