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Идёт набор NCT06919562

OPtimal stEnt Deployment stRategy oF Contemporary sTents - Registry to Evaluate Percutaneous Coronary Intervention Using Bioresorbable Scaffolds With Thinner-strut Construction and Guidance by intracOronary Imaging to REduce Scaffold Failure

— Наблюдательное Coronary Arterial Disease (CAD) Percutaneous Coronary Intervention (PCI)

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: Percutaneous coronary intervention with protocolized implantation of a second generation thin-strut bioresorbable scaffold guided by intracoronary imaging.
Кому может быть актуально
Состояния в реестре: Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI). 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
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Implantation of a metallic drug-eluting stent (DES) is currently the gold standard in percutaneous coronary intervention (PCI). However, a DES has several limitations on the long-term, such as chronic local inflammation which may lead to in-stent restenosis, absence of physiological coronary vasomotion and vessel caging which makes future coronary artery bypass grafting (CABG) impossible. A bioresorbable scaffold (BRS) is designed to overcome these limitations. The first generation BRS was shown to be clinically inferior to DES due to a slightly higher rate of stent thrombosis. To overcome this problem, several scientific developments have been achieved in the past few years, such as thinner BRS strut construction and improved implantation technique by using PSP (predilatation, sizing, postdilatation) method and intracoronary imaging guidance with optical coherence tomography (OCT) or intravasculair ultrasound (IVUS). A PCI protocol that combines implantation of a second generation thin-strut BRS, mandatory PSP implantation method and mandatory intracoronary imaging-guidance has not yet been investigated. The aim of this study is to investigate feasibility of a new PCI protocol with implantation of the second generation Meres100 thin-strut BRS combined with a protocolized PSP implantation technique guided by intracoronary imaging.

Вмешательства

  • Процедура Percutaneous coronary intervention with protocolized implantation of a second generation thin-strut bioresorbable scaffold guided by intracoronary imaging
    Percutaneous coronary intervention (PCI) with implantation of the MeRes100 thin-strut BRS with protocolized PSP (predilatation, sizing, postdilatation) method and intracoronary imaging guidance.

Первичные конечные точки

  • Technical success [Срок оценки: End of procedure]
  • Angiographic success [Срок оценки: End of procedure]
  • Treatment protocol adherence [Срок оценки: End of procedure]
  • Optimal scaffold result [Срок оценки: End of procedure]
  • Additional optimization steps [Срок оценки: End of procedure]
  • Target Lesion Failure [Срок оценки: 1-year and 3-year post-procedure]
  • Scaffold thrombosis [Срок оценки: 1-year and 3-year post-procedure]
Вторичные конечные точки (5)
  • Minimal scaffold area [Срок оценки: End of procedure]
  • Scaffold malapposition [Срок оценки: End of procedure]
  • Scaffold expansion [Срок оценки: End of procedure]
  • Edge dissection [Срок оценки: End of procedure]
  • Intra-scaffold plaque protrusion and thrombus [Срок оценки: End of procedure]

Критерии участия

Критерии включения

  • Stable coronary artery disease with one or more significant epicardial stenosis in native coronary arteries suitable for OCT or IVUS-guided PCI with BRS implantation.
  • Subject must be at least 18 years of age
  • Written consent to participate in the study

Критерии исключения

  • Culprit lesions in the setting of acute coronary syndrome.
  • Lesions with severe calcification.
  • Lesions in a coronary artery with severe tortuosity.
  • Left main coronary artery lesions.
  • Bifurcation lesions.
  • Ostial lesions.
  • Lesions with a difference in proximal and distal reference diameter of >0.5 mm by visual judgement of the coronary angiogram by the treating operator.
  • Treatment of in-stent restenosis or stent thrombosis.
  • History of definite stent thrombosis.
  • Lesions in coronary artery bypass grafts.
  • Lesions not suitable for OCT or IVUS catheter delivery and imaging, e.g. due to tortuosity or distal localisation.
  • Creatinine Clearance ≤ 30 ml/min/1.73 m2 as calculated by MDRD formula for estimated GFR.
  • Contraindication to dual antiplatelet therapy with aspirin and a P2Y12 inhibitor or (if indicated) NOAC and P2Y12 inhibitor.
  • Planned non-deferrable major surgery after PCI.
  • Known comorbidity associated with a life expectancy <1 year.
  • Unable to understand and follow study-related instructions or unable to comply with study protocol.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Нидерланды · 1 центр
  • Albert Schweitzer ziekenhuis — Dordrecht

Идентификаторы

NCT: NCT06919562 · PERFECT RESTORE · NL-009177

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗