Intravascular Imaging-Guided Intravascular Lithotripsy for Severe Coronary Calcified Lesions.

Официальное название

Intravascular Imaging-Guided Intravascular Lithotripsy for Severe Coronary Calcified Lesions, a Prospective,Observational, Single-center Registry Study.

Обзор

This study aims to investigate the efficacy and safety of intravascular lithotripsy (IVL) balloon in treating coronary calcified lesions at our center.

Подробное описание

Coronary artery calcification is caused by the deposition of calcium within the coronary arteries, leading to increased vascular stiffness and serving as an independent risk factor for adverse cardiovascular events in patients with coronary artery disease. During percutaneous coronary intervention (PCI) for severe coronary artery calcification, procedural challenges such as device delivery difficulties, inadequate balloon expansion, incomplete stent deployment, and even coronary artery perforation are frequently encountered. Therefore, the identification and pretreatment of calcified lesions are of paramount importance in PCI procedures. This study aims to investigate the efficacy and safety of intravascular lithotripsy (IVL) balloons for treating coronary calcified lesions at our center. Using a consecutive enrollment approach, patients with moderate to severe coronary artery calcification will undergo IVL treatment under the guidance of optical coherence tomography (OCT) or intravascular ultrasound (IVUS). Clinical data, procedural parameters, and intracoronary imaging data will be collected to establish a clinical-intracoronary imaging database for patients with severe coronary artery calcification, including subgroups such as acute coronary syndrome (ACS), chronic coronary syndrome (CCS), and cases of incomplete stent expansion. The study will address the following objectives: Evaluate the efficacy and safety of IVL in treating severe coronary artery calcification. Analyze factors influencing residual stenosis immediately after PCI and develop a machine learning-based risk prediction model for moderate or greater residual stenosis (residual stenosis \> 30%). Compare the efficacy of different intracoronary imaging modalities (IVUS vs. OCT) in guiding IVL for the pretreatment of severe coronary calcified lesions. Investigate the application of IVL balloons in treating calcified nodules.

Вмешательства

• Процедура percutaneous coronary intervention
  All enrolled patients underwent Intravascular Lithotripsy (IVL) and Percutaneous Coronary Intervention (PCI) under guideline-directed management.

Первичные конечные точки

• MACE: All-Cause Death, Recurrent Myocardial Infarction, Unplanned Target Vessel Revascularization, Acute Stent Thrombosis. [Срок оценки: Periprocedurally and 6 months after PCI]

Вторичные конечные точки (1)

• Residual stenosis rate after PCI. [Срок оценки: Immediately after the PCI]

Критерии участия

Критерии включения

• Patients with coronary angiography showing vessel diameter stenosis ≥ 70% and moderate to severe calcification;
• Reference vessel diameter ≥ 2.5 mm;
• Signed informed consent form.

Критерии исключения

• Patients with comorbid conditions such as malignant tumors and an expected lifespan of less than 1 year;
• Patients with hemodynamic instability;
• Patients classified as New York Heart Association (NYHA) functional class IV;
• Any other conditions deemed by the investigator as unsuitable for enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• First Affiliated Hospital of Nanjing Medical University — Нанкин

Публикации

• Oomens T, Vos NS, van der Schaaf RJ, Amoroso G, Ewing MM, Patterson MS, Herrman JR, Slagboom T, Vink MA. EXpansion of stents after intravascular lithoTripsy versus conventional predilatation in CALCified coronary arteries. Int J Cardiol. 2023 Sep 1;386:24-29. doi: 10.1016/j.ijcard.2023.05.012. Epub 2023 May 12. PMID 37178801
• Hill JM, Kereiakes DJ, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. J Am Coll Cardiol. 2020 Dec 1;76(22):2635-2646. doi: 10.1016/j.jacc.2020.09.603. Epub 2020 Oct 15. PMID 33069849

Идентификаторы

NCT: NCT07444346 · 033

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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