Sirolimus-Coated vs Paclitaxel-Coated DCBs in ACS Treatment

Официальное название

Comparison Study of Sirolimus-Coated Versus Paclitaxel-Coated Coronary Drug-Coated Balloons in the Treatment of Acute Coronary Syndrome

Обзор

This study aims to investigate and compare the local inflammatory responses and plaque healing characteristics between sirolimus-coated and paclitaxel-coated coronary drug-coated balloons in patients with acute coronary syndrome.

Подробное описание

This prospective, single-center, randomized, controlled trial aims to evaluate and compare the differential effects of sirolimus-coated versus paclitaxel-coated drug-coated balloons (DCBs) on local inflammatory responses and plaque healing characteristics in patients with acute coronary syndrome (ACS) with optical coherence tomography (OCT).

Вмешательства

• Устройство Sirolimus-coated DCB
  Treatment of sirolimus-coated DCB
• Устройство Paclitaxel-coated DCB
  Treatment of paclitaxel-coated DCB

Первичные конечные точки

• Optical coherence tomography assessment of target lesion healing and repair at 3-month follow-up after the procedure [Срок оценки: 3 months]

Вторичные конечные точки (12)

• OCT-measured minimum lumen area change at 3 months post-procedure [Срок оценки: 3 months]
• OCT-measured fibrous cap thickness change at 3 months post-procedure [Срок оценки: 3 months]
• OCT-measured maximum lipid arc change at 3 months post-procedure [Срок оценки: 3 months]
• OCT assessment of macrophage infiltration change at 3 months post-procedure [Срок оценки: 3 months]
• OCT-measured thin-cap fibroatheroma count change at 3 months post-procedure [Срок оценки: 3 months]
• OCT-measured lipid pool length change at 3 months post-procedure [Срок оценки: 3 months]
• OCT assessment of microchannel change at 3 months post-procedure [Срок оценки: 3 months]
• OCT-measured minimum lumen diameter change at 3 months post-procedure [Срок оценки: 3 months]
• CCTA-measured perivascular fat attenuation index change at 6 months [Срок оценки: 6 months]
• CCTA-measured low-attenuation plaque volume change at 6 months post-procedure [Срок оценки: 6 months]
• CCTA-measured plaque burden change at 6 months post-procedure [Срок оценки: 6 months]
• Incidence of target lesion failure (TLF) at 6 months post-procedure [Срок оценки: 6 months]

Критерии участия

Критерии включения

Subjects must meet all of the following criteria to be enrolled:

• Age between 18 and 80 years old, both genders eligible;
• Coronary angiography showing non-complex lesions with acute coronary syndrome (non-ST-elevation myocardial infarction and unstable angina) deemed suitable for drug-coated balloon treatment by the investigator;
• Visually estimated lesion length ≤28mm, visually estimated vessel diameter ≥2.5mm and ≤3.0mm;
• Successful lesion pre-dilation (must simultaneously meet all 3 criteria: no Type C or greater dissection; TIMI flow grade 3; visually estimated residual stenosis ≤30%);
• Able to understand the study purpose, willing to complete follow-up visits, and voluntarily provide informed consent.

Критерии исключения

Subjects will be excluded if they meet any of the following criteria:

• Total occlusion (TIMI 0 flow) lesion;
• In-stent restenosis lesion;
• Concurrent left main disease or severe three-vessel disease requiring coronary artery bypass grafting;
• Target lesion with severe calcification or tortuosity that cannot be crossed by guidewire;
• Coronary artery bypass graft stenosis;
• Confirmed ST-elevation myocardial infarction;
• Cardiogenic shock or requiring mechanical respiratory and circulatory support;
• Hemodynamically unstable tachyarrhythmia or bradyarrhythmia;
• Severe renal insufficiency or undergoing hemodialysis;
• Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, heparin, contrast media, paclitaxel, sirolimus and/or other analogues;
• Systemic lupus erythematosus or other systemic autoimmune diseases;
• History of stroke within 6 months prior to enrollment;
• Scheduled elective surgery within 6 months after enrollment requiring discontinuation of anticoagulant or antiplatelet medications;
• Currently participating in other drug or interventional medical device clinical studies;
• Other conditions deemed unsuitable for enrollment by the investigator.

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 · 1 центр

• Fuwai hospital, CAMS&PUMC — Пекин

Идентификаторы

NCT: NCT07514988 · RWT-P/S-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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