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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Jun Jiang, MD, PhD
- Numer telefonu: 86-571-8778-3992
- E-mail: jiang-jun@zju.edu.cn
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Age ≥ 18 years;
- Target lesion with diameter stenosis ≥ 50% (visual estimation) associated with evidence of myocardial ischemia;
- 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);
- Target vessel reference diameter between 2.5 and 4.0 mm, with successful guidewire traversal;
- A maximum of two non-target lesions requiring interventional treatment, which must be successfully treated prior to the target lesion;
- Patients presenting with evidence of symptomatic or asymptomatic myocardial ischemia, stable or unstable angina pectoris, or prior myocardial infarction;
- Signed written informed consent obtained.
Exclusion Criteria:
- Cardiogenic shock or hemodynamic instability;
- Chronic total occlusion (CTO);
- Requirement for intraprocedural mechanical circulatory support, such as intra-aortic balloon pump (IABP) or Impella device;
- Acute ST-segment elevation myocardial infarction (STEMI) occurring within 1 month prior to enrollment;
- Angiographically visible thrombus at the target lesion site;
- Left main ostial lesion with stenosis ≥ 50%;
- Left ventricular ejection fraction (LVEF) < 40%;
- New-onset stroke or transient ischemic attack (TIA) within 90 days;
- Bypass graft lesion;
- Coronary artery dissection of type B or greater (NHLBI classification);
- Pregnant or lactating patients;
- Life expectancy < 1 year;
- Active bleeding;
- Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m²;
- Presence of cognitive or psychiatric disorders, as confirmed by clinical diagnosis or investigator assessment;
- 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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny 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
|
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
|
|
Aktywny 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
|
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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
minimal stent area
Ramy czasowe: Within one hour post-percutaneous coronary intervention
|
Within one hour post-percutaneous coronary intervention
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Inne miary wyników
Miara wyniku |
Ramy czasowe |
|---|---|
|
uszkodzenie naczynia docelowego
Ramy czasowe: 1 rok
|
1 rok
|
|
major adverse cardiac event
Ramy czasowe: 1 year
|
1 year
|
|
success rate of PCI
Ramy czasowe: Within one hour post-percutaneous coronary intervention
|
Within one hour post-percutaneous coronary intervention
|
|
complications during perioperative period
Ramy czasowe: during perioperative period
|
during perioperative period
|
|
IVUS image feature analysis
Ramy czasowe: Within one hour post-percutaneous coronary intervention
|
Within one hour post-percutaneous coronary intervention
|
|
TnT+CK/CKMB
Ramy czasowe: 24 hours post-PCI
|
24 hours post-PCI
|
|
The dosage of contrast agent, the amount of X-rays exposed and the operation time
Ramy czasowe: during the PCI
|
during the PCI
|
|
Subgroup analysis of gender, age, diabetes, etc
Ramy czasowe: 1 year
|
1 year
|
|
The differences and influences of computational physiology and microcirculation between the two groups of patients
Ramy czasowe: 1 year
|
1 year
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Techniki śledcze
- Lecznictwo
- Procedury chirurgiczne, operacyjny
- Angioplastyka
- Cewnikowanie
- Procedury wewnątrznaczyniowe
- Naczyniowe procedury chirurgiczne
- Procedury chirurgiczne sercowo -naczyniowe
- Minimalnie inwazyjne procedury chirurgiczne
- Atherektomia
- Rewaskularyzacja mięśnia sercowego
- Procedury chirurgiczne serca
- Przezskórna interwencja wieńcowa
- Procedury chirurgiczne klatki piersiowej
- Atherektomia, wieńcowa
Inne numery identyfikacyjne badania
- 2026-0688
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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