Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

3. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

190

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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
Verfahren: 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
Aktiver 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
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
minimal stent area
Zeitfenster: Within one hour post-percutaneous coronary intervention
Within one hour post-percutaneous coronary intervention

Andere Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

30. September 2029

Studienabschluss (Geschätzt)

30. Juni 2030

Studienanmeldedaten

Zuerst eingereicht

15. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. August 2026

Zuerst gepostet (Tatsächlich)

6. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. August 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026-0688

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren