Scaffold in Emilia Romagna and in the MAGIC Network
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: scaffold.
- Кому может быть актуально
- Состояния в реестре: Coronary Artery Disease. 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
- Италия
- 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
Scaffold Implantation in Emilia-Romagna Plus Multi Absorbable Gears Intra Coronary
Обзор
The prospective study will investigate the clinical performance and long-term safety of scaffold implantation in a real world regional setting. The protocol includes two different networks. The first network includes all cath-labs in the Emilia-Romagna region (SHERPA). The second includes the centers partecipating into the MAGIC retrospective study. Both networks joined into the prospective SHERPA-MAGIC project. Investigators from both networks agreed in indications and strategy implanatation described by the protocol. In each center, after IRB approval, the patients will be enrolled according to established criteria.
Подробное описание
Coronary stents are the default devices for the treatment of coronary artery disease in percutaneous coronary intervention (PCI) according to existing guidelines. However, thrombosis and restenosis are still the main limitations of current permanent metallic stents. In contrast to Bare Metal Stents (BMSs), Drug Eluting Stents (DESs) have a reduced restenosis rate due to the presence of antiproliferative agents in the coating layer of the stent surface and reduced rate of repeat revascularisation. However, late and very late stent thrombosis remains the limitation of DES in spite of prolonged dual antiplatelet therapy. Bioabsorbable scaffolds have been introduced to overcome limitations of permanent metallic stents.
The aim of this observational prospective study is to investigate the clinical performance and long-term safety of scaffold in a real world regional setting.
The investigators agreed in the following preferential/optimal indications:
* complete revascularization in patients with age \<65 years * revascularization of long lesions (\>24 mm), especially located in left anterior descending * spontaneous coronary dissection
The investigators agreed in the following strategy implantation:
* mandatory predilatation * sizing 1:1 * to avoid vessel with reference vessel diameter \<2.8 mm and \>3.8 mm * to avoid vessel with severe calcifications * mandatory postdilation with non compliant balloon ≥0.5 the scaffold diameter
The study organization is based on:
DATA SAFETY MONITORING BOARD (DSMB) All adverse events will be reported to the DSMB and reviewed on an on-going basis throughout the subject enrolment and follow-up period to ensure the safety of subjects enrolled in this study. The DSMB may request additional information as needed.
CORE LABORATORY ANALYSIS All coronary artery angiographies and percutaneous coronary interventions will be reviewed by an indipendent core-lab. The core-lab will perform quantitative coronary analysis and assessment of the agreement between implantation technique in each case and established criteria
Вмешательства
- Устройство scaffold
implantation of scaffold (eg Magmaris, Desolve, Others)
Первичные конечные точки
- Device Oriented Cardiac Events [Срок оценки: 1 year]
Критерии участия
Критерии включения
- subjects >18 years
- sign of the patients informed consent
- implanation of at least one scaffold
Критерии исключения
- inability to garantuee at least one year follow-up
- inabiliuty to garantuee at least one year compliance to dual antiplatelet regimen
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 17 центров
- AO San Giovanni di Dio — Agrigento
- Ospedale Caravaggio-Treviglio — Treviglio
- Azienda Ospedaliera Universitaria di Bologna — Bologna
- U.O. Cardiologia, Ospedale Maggiore — Bologna
- Ospedale SS Annunziata — Savigliano
- University Hospital of Ferrara — Cona
- U.O. Cardiologia, Ospedale Morgagni Pierantoni — Forlì
- U.O. Cardiologia, Azienda Ospedaliera Universitaria di Modena, Policlinico — Modena
- … и ещё 9 центров
Идентификаторы
NCT: NCT03327961 · 170899