Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions

Официальное название

Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions: a Randomized Controlled Trial (Shape)

Обзор

this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions

Подробное описание

Calcified lesions posed a significant challenge in percutaneous coronary intervention (PCI). The existence of calcified plaque increased the difficulty of optimal stent expansion and the risk of target lesion failure(TLF). Consequently, optimizing the preparation techniques for calcified lesions before stent implantation has assumed growing importance.

As a kind of novel double-layered balloon, super high-pressure balloon can expand uniformly under extreme pressure. Previous studies have demonstrated that super high-pressure balloon perform non-inferiorly or superiorly to other strategies in terms of final stent expansion.

Through triggering localized pulsatile sonic pressure, intravascular lithotripsy(IVL) cracked intimal and medial calcium plaque within the artery. In present series of studies(DISRUPT), the optimized preparation of calcified lesions with IVL has been proved to be safe and effective. According to guidelines and clinical practice, IVL is applicable to different types of severe calcification lesions, including concentric and eccentric calcifications. However, considering its technological and economic costs, finding other preparation techniques non-inferiority to IVL was essential. In clinical practice, super high-pressure balloon had shown considerable effects of preparation for calcified lesions. However, study focused on the comparison of super high-pressure balloon with IVL for severe calcified lesions was limited.

In summary, this randomized trial aimed to evaluate the stent expansion through intravascular imaging among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions

Вмешательства

• Устройство super high-pressure balloon
  preparation strategy for calcified lesions after unsatisfactory dilation
• Устройство intravascular lithotripsy (IVL)
  preparation strategy for calcified lesions after unsatisfactory dilation

Первичные конечные точки

• stent expansion index [Срок оценки: Intraprocedural]

Вторичные конечные точки (1)

• 30-days major adverse cardiac event (MACE) [Срок оценки: 30 days]

Критерии участия

Критерии включения

• Age > 18 years and < 80 years
• Presented as asymptomatic angina, stable angina, unstable angina, prior myocardial infarction (MI), or non-ST-elevation myocardial infarction (NSTEMI).
• Have an indication for drug-eluting stent (DES) implantation
• Denovo coronary artery calcified lesions
• Target lesion diameter stenosis ≥ 70%, or target lesion diameter stenosis between ≥ 50% and < 70%, accompanied by evidence of myocardial ischemia(such as fractional flow reserve (FFR) ≤ 0.80 or minimal lumen area (MLA) ≤ 4.0 mm²).
• Reference vessel diameter of the target vessel between 2.5 mm - 4.5 mm
• Maximum calcium arc within the lesion ≥ 270⁰ assessed by optical coherence tomography (OCT) or intravascular ultrasound (IVUS)
• Unsatisfactory lesion preparation with non-compliant balloon, defined as baseline diameter stenosis reduction of < 30% under maximal inflation pressure.
• Provision of written informed consent

Критерии исключения

• Presented as acute ST-segment elevation myocardial infarction (STEMI), cardiogenic shock and multiple organ failure
• Presented as severe contrast agent allergy
• Intolerant to dual antiplatelet therapy (DAPT) and/or anticoagulation therapy
• Presented as active phase of autoimmune disease
• Calcified nodules or eccentric calcification lesions
• Failure to reach the target lesion with guidewires or catheters
• Complex coronary bifurcation lesions
• Target vessel thrombosis or aneurysm within 10 mm of the target lesion

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Lianyungang First People's Hospital — Lianyungang
• Nanjing First Hospital — Нанкин
• Yixing People's Hospital — Yixing

Публикации

• Cassese S, Simonetti F, Covarrubias HAA, Janisch M, Joner M, Kufner S, Lenz T, Pellegrini C, Rheude T, Sager H, Schunkert H, Starnecker F, Voll F, Xhepa E, Kastrati A, Kessler T. Intracoronary stenting and additional results achieved by shockWAVE coronary lithotripsy: design and rationale of ISAR-WAVE trial. Am Heart J. 2025 Apr;282:1-12. doi: 10.1016/j.ahj.2024.12.008. Epub 2024 Dec 20. PMID 39710352
• Sagris M, Ktenopoulos N, Dimitriadis K, Papanikolaou A, Tzoumas A, Terentes-Printzios D, Synetos A, Soulaidopoulos S, Lichtenberg M, Korosoglou G, Honton B, Tousoulis D, Tsioufis C, Toutouzas K. Efficacy of intravascular lithotripsy (IVL) in coronary stenosis with severe calcification: A multicenter systematic review and meta-analysis. Catheter Cardiovasc Interv. 2024 Apr;103(5):710-721. doi: 10.1 PMID 38482928
• Rheude T, Rai H, Richardt G, Allali A, Abdel-Wahab M, Sulimov DS, Mashayekhi K, Ayoub M, Cuculi F, Bossard M, Kufner S, Xhepa E, Kastrati A, Fusaro M, Joner M, Byrne RA, Cassese S. Super high-pressure balloon versus scoring balloon to prepare severely calcified coronary lesions: the ISAR-CALC randomised trial. EuroIntervention. 2021 Aug 27;17(6):481-488. doi: 10.4244/EIJ-D-20-01000. PMID 33258774
• Rheude T, Fitzgerald S, Allali A, Mashayekhi K, Gori T, Cuculi F, Kufner S, Hemetsberger R, Sulimov DS, Rai H, Ayoub M, Bossard M, Xhepa E, Fusaro M, Toelg R, Joner M, Byrne RA, Richardt G, Kastrati A, Cassese S, Abdel-Wahab M. Rotational Atherectomy or Balloon-Based Techniques to Prepare Severely Calcified Coronary Lesions. JACC Cardiovasc Interv. 2022 Sep 26;15(18):1864-1874. doi: 10.1016/j.jcin PMID 36137691

Идентификаторы

NCT: NCT07093788 · KY20250425-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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