Dynamic Change of Coronary Artery Curvature (DC3)
Dynamic Change of Coronary Artery Curvature After Adaptive Remodeling
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Coronary artery disease (CAD) is the most common type of heart disease and the leading cause of death worldwide. Percutaneous coronary intervention and coronary artery bypass graft are the guideline suggested treatment. Drug-eluting stents (DES) is the guideline suggested treatment options. Percutaneous coronary intervention with DES provides not just acute luminal gains, but also good long-term patency and clinical outcomes. However, in-stent neoatherosclerosis, very late stent thrombosis, and endothelial dysfunction remained important long-term issues. In addition, metallic stent encages the vessel segment, limits its remodeling and vasomotor function. The original vessel geometry, curvature, tortuosity, and wall shear stress, which are associated with plaque formation are also changed permanently by stent implantation. Although bioresorbable scaffolds attempted to address these issues by providing structural support to the vessel early on, followed by resorption, randomized trials showed that, prior to their resorption, they were less safe and effective than contemporary DES. Since that, the novel DES, DynamX Bioadaptor, is designed to improve these limitations.
The novel DES, DynamX Bioadaptor, is designed to restore normal pulsatility and adaptive remodeling in blood vessels after stent implantation. It is a cobalt-chromium stent with a biodegradable polymer coating that releases novolimus. Segments of the stent are held together by the polymer coating, which is designed to be fully absorbed in 6 months. After degradation of polymer, the stent struts unlink and uncage the stented segment. Pilot study demonstrated vessel uncaging and restoration of cyclic pulsatility 12 months after DynamX Bioadaptor implantation. Adaptive remodeling 12 months after DynamX Bioadaptor implantation will restore flexibility and natural geometry of the stented vessel segment. Thus, the dynamic beat-to-beat (cardiac cycle) changes of curvature and tortuosity will be more pronounced in the DynamX Bioadaptor group compared with that in the permanent metallic Elixir DESyne DES group. The DynamX Bioadaptor can potentially restore the vessel geometry and improve outcomes. The present randomized control study is designed to investigate the differences of dynamic coronary artery geometry changes after DynamX Bioadaptor and permanent metallic DES implantation, using coronary computed tomography angiography (CCTA) as an evaluation tool.
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Hsien-Li Kao, MD
- Номер телефона: 62152 +886-2-23123456
- Электронная почта: hsienli_kao@yahoo.com
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Patient is ≥ 20 years old.
- Written informed consent can be obtained.
- The enrolled coronary vessel only has one target coronary lesion required stenting.
- The target coronary lesion is 50 to 100% stenosis and stenting is required.
- Coronary artery de novo lesion requiring implantation of a single drug eluting stent with length ≥ 32 mm.
- Patients are able to tolerate dual antiplatelets for at least six months.
Exclusion Criteria:
- Patient is unwilling to join this study.
- Patients have end-stage renal disease under dialysis, chronic kidney disease (serum creatine > 1.5 mg/dL), symptomatic heart failure, active cancer, high bleeding risk, ST elevation myocardial infarction or hemodynamic unstable non-ST elevation myocardial infarction.
- Coronary lesion with following features: heavily calcification, ostial lesion, lesions requiring post-stenting side branch dilatation and lesions required more than one stent to treat.
- The left ventricular ejection fraction is ≤ 40%.
- No scheduled operation within six months after the coronary stenting is allowed unless continuous dual antiplatelet use is acceptable.
- Patients are unsuitable or unable to receive CCTA.
- Pregnant women or women with breast feeding or suitable pregnant women without contraception during the study period.
- Patient is currently participating another interventional trial.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: DynamX Bioadaptor
Patients were randomized during the percutaneous coronary intervention before stent implantation and assigned to the study arm using an electronic spreadsheet indicating the group assignment by random numbers.
The patients will be 1:1 randomized to 2 groups: DynamX Bioadaptor and DESyne DES groups.
|
Patients received percutaneous coronary intervention in a similar way to a traditional DES.
Patients first receive radial artery or femoral artery cannulation with anticoagulation during the intervention.
All coronary angiograms are carefully measured by at least 2 orthographic views and performed under the same standard conditions.
After adequate predilatation of the target lesion, the coronary stenting will be performed.
All patients will receive a loading dose of acetylsalicylic acid and a P2Y12 inhibitor pre-procedure followed by dual antiplatelet therapy for at least 6 months.
Другие имена:
|
|
Активный компаратор: DESyne Drug-eluting Stent
Patients were randomized during the percutaneous coronary intervention before stent implantation and assigned to the study arm using an electronic spreadsheet indicating the group assignment by random numbers.
The patients will be 1:1 randomized to 2 groups: DynamX Bioadaptor and DESyne DES groups.
|
Patients received percutaneous coronary intervention in a similar way to a traditional DES.
Patients first receive radial artery or femoral artery cannulation with anticoagulation during the intervention.
All coronary angiograms are carefully measured by at least 2 orthographic views and performed under the same standard conditions.
After adequate predilatation of the target lesion, the coronary stenting will be performed.
All patients will receive a loading dose of acetylsalicylic acid and a P2Y12 inhibitor pre-procedure followed by dual antiplatelet therapy for at least 6 months.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
The differences of vessel curvature change and tortuosity
Временное ограничение: 12 months ± 2 weeks
|
The differences of vessel curvature change during systolic-diastolic phases, 12 months ± 2 weeks after DynamX Bioadaptor or Elixir DESyne DES implantation, measured by CCTA.
|
12 months ± 2 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
The differences of vessel tortuosity change
Временное ограничение: 12 months ± 2 weeks
|
The differences of vessel tortuosity change during systolic-diastolic phases, 12 months ± 2 weeks after DynamX Bioadaptor or Elixir DESyne DES implantation, measured by CCTA.
|
12 months ± 2 weeks
|
|
New plaque formation related in-stent/in-segment restenosis
Временное ограничение: 12 months ± 2 weeks
|
In-stent/in-segment restenosis 12 months ± 2 weeks after DynamX Bioadaptor or Elixir DESyne DES implantation, measured by CCTA.
|
12 months ± 2 weeks
|
Соавторы и исследователи
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Ожидаемый)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 202101142DIPA
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования DynamX Bioadaptor
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Elixir Medical CorporationЗавершенный
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Elixir Medical CorporationРекрутингИшемическая болезнь сердцаСаудовская Аравия
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Elixir Medical CorporationIstituto Clinico HumanitasАктивный, не рекрутирующийИшемическая болезнь сердца | Хроническая тотальная окклюзия коронарной артерии | Многососудистое заболевание коронарных артерий | Бифуркация коронарной артерии | Длинные поражения коронарной артерииИталия
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Elixir Medical CorporationUppsala UniversityАктивный, не рекрутирующийИшемическая болезнь сердца | Ишемическая болезнь сердцаШвеция
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Elixir Medical CorporationЗавершенныйИшемическая болезнь сердцаНовая Зеландия