Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Paclitaxel Drug-coated balloon.
- Кому может быть актуально
- Состояния в реестре: Coronary Artery Disease, Total Occlusion of Coronary Artery. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Польша
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention (IMAGINATION)
Обзор
The IMAGINATION trial is an investigator-initiated, prospective, single-center study of symptomatic patients with a native chronic total occlusion (CTO) undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB). Post-PCI IVUS and fractional flow reserve (FFR) at baseline and at 6-months follow-up will be performed. In addition, patients included in the coronary computed tomography angiography (CCTA) substudy will undergo CCTA at 12-months follow-up. The aim of this study is to evaluate the efficacy and safety of DCB-only approach in native coronary CTO.
Подробное описание
Whereas CTO PCI techniques and success rates have significantly improved during the last decade, CTOs still pose a significant technical challenge for accurate stent sizing (primarily due to negative remodelling and subsequent distal vessel dilatation post-PCI) resulting in a potentially increased risk of stent failure. Hence, the concept of DCB as a definitive treatment for native CTO is appealing and warrants further investigation. The IMAGINATION trial has been designed as a prospective research to: 1) investigate both the immediate and intermediate-term angiographic, IVUS and physiologic efficacy outcomes as well as safety profile of DCB for native vessel coronary CTO, and 2) to provide a basis for future randomized clinical trial comparing DCB to drug-eluting stents.
All patients with CTO will be screened for potential inclusion in the study. After obtaining written informed consent, patients with successful intraplaque guidewire crossing through CTO lesion (excluding the use of dissection and re-entry techniques) will undergo IVUS-guided PCI with a scoring balloon (balloon-to-artery ratio of 1:1) followed by the use of a paclitaxel-coated balloon. Following satisfactory angiographic result, IVUS and physiological measurements (FFR and non-hyperemic pressure ratios) in the target vessel will be performed. At 6-months follow-up, invasive angiography with IVUS and FFR/non-hyperemic pressure ratios in the target vessel will be repeated. In addition, patients with pre-procedural CCTA will undergo follow-up CCTA after 12 months (CCTA substudy).
Вмешательства
- Устройство Paclitaxel Drug-coated balloon
Percutaneous coronary intervention of the actual CTO body with a paclitaxel drug-coated balloon.
Первичные конечные точки
- In-segment late lumen loss [Срок оценки: 6-months]
Вторичные конечные точки (8)
- Angiographic outcomes assessed directly post-PCI [Срок оценки: immediately post-procedure (1 day)]
- HD-IVUS outcomes assessed directly post-PCI [Срок оценки: immediately post-procedure (1 day)]
- Physiologic outcomes assessed directly post-PCI [Срок оценки: immediately post-procedure (1 day)]
- Angiographic outcomes at 6-months follow-up [Срок оценки: 6-months]
- HD-IVUS outcomes at 6-months follow-up [Срок оценки: 6-months]
- Physiologic outcomes at 6-months follow-up [Срок оценки: 6-months]
- Computed tomographic outcomes at 12-months follow-up (CCTA substudy) [Срок оценки: 12-months]
- Clinical outcomes at 12-months follow-up [Срок оценки: 12-months]
Критерии участия
Критерии включения
- clinical indication for CTO PCI as determined by the local heart team (presence of angina or equivalent symptoms and/or documented ischemia or viability)
- native CTO lesion as defined by invasive coronary angiography
- informed consent for participation in the study
Критерии исключения
- <18 years of age
- myocardial infarction
- cardiogenic shock
- severe valvular disease
- estimated life expectancy <1 year
- contraindication to PCI
- positive pregnancy test or breast-feeding
- in-stent CTO
- CTO recanalization using antegrade or retrograde dissection and re-entry techniques
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Польша · 1 центр
- National Institute of Cardiology — Warsaw
Идентификаторы
NCT: NCT06275386 · 2.31/II/24