Идёт набор NCT07230847

A Study Evaluating the Vascular Healing and Neointimal Transformation at 1 Month After Implantation of BioFreedom™ Drug-coated Stents and the Xience Drug-eluting Stent System in Patients With Acute Coronary Syndrome and High Bleeding Risk Using Optical Coherence Tomography

Без фазы С лечением Coronary Heart Disease Acute Coronary Syndrome

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: BioFreedom™, Xience.
Кому может быть актуально: Состояния в реестре: Coronary Heart Disease, Acute Coronary Syndrome. 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: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

BioFreedom™ is the world's first polymer-free drug-coated stent (DCS), utilizing a proprietary microstructured surface technology. Its abluminal microporous surface directly carries BA9™ (a sirolimus derivative) with high lipophilicity. This design mitigates inflammatory responses while promoting early vascular healing and reducing thrombotic risk. Extensive clinical evidence has validated BioFreedom™'s superior performance in high-bleeding-risk (HBR) populations. However, comprehensive assessments of neointimal coverage and quantitative neointimal transformation post-implantation remain insufficient. With advancements in ultra-high-resolution optical coherence tomography (OCT), detailed evaluation of coronary stent healing has become feasible. This study will employ OCT to comparatively assess vascular healing patterns-including neointimal transformation and strut coverage-in ACS patients with HBR receiving either the commercially available BioFreedom™ DCS or Xience drug-eluting stent system. The findings will provide multidimensional insights into the devices' post-implantation efficacy and safety profiles.

Вмешательства

Устройство BioFreedom™
BioFreedom™ Drug-Coated Coronary Stent Intervention
Устройство Xience
Xience Drug-Eluting Coronary Stent System Intervention

Первичные конечные точки

OCT-Detected Neointimal Strut Coverage at 1-Month Post-Procedure [Срок оценки: 1-Month Post-Procedural Follow-Up]

Вторичные конечные точки (6)

Neointimal thickness at 1-month post-procedure [Срок оценки: 1-Month Post-Procedural Follow-Up]
Neointimal area at 1-month post-procedure [Срок оценки: 1-Month Post-Procedure Follow-Up]
Neointimal volume at 1-month post-procedure [Срок оценки: 1-Month Post-Procedure Follow-Up]
Incidence of Major Adverse Cardiac Events (MACE) within 12 Months Post-Procedure [Срок оценки: 12 Months Post-Procedure]
Incidence of stent thrombosis within 12 months post-procedure [Срок оценки: 12 Months Post-Procedure]
Incidence of bleeding events within 12 months post-procedure [Срок оценки: 12 Months Post-Procedure]

Критерии участия

Критерии включения

Age ≥18 years
Male or non-pregnant female
Acute coronary syndrome (ACS) patients requiring percutaneous coronary intervention (PCI)
No contraindications for coronary artery bypass grafting (CABG)
High bleeding risk (HBR) patients per ARC-HBR definition (meeting ≥1 major or 2 minor criteria):

Major Criteria:

Expected long-term oral anticoagulation
Severe/end-stage chronic kidney disease (eGFR <30 mL/min)
Moderate/severe anemia (Hb <110 g/L)
Spontaneous bleeding requiring hospitalization/transfusion within 6 months (or recurrent)
Chronic bleeding diathesis
Moderate/severe thrombocytopenia pre-PCI (platelet count <100×10⁹/L)
Liver cirrhosis with portal hypertension
Active malignancy in past 12 months (excluding non-melanoma skin cancer; defined as diagnosis/treatment within 12 months)
History of spontaneous intracranial hemorrhage
Traumatic intracranial hemorrhage within 12 months
Known cerebral arteriovenous malformation
Moderate/severe ischemic stroke within 6 months
Major surgery/severe trauma within 30 days pre-PCI
Planned non-deferrable major surgery during dual antiplatelet therapy

Minor Criteria:

Age ≥75 years
Moderate chronic kidney disease (eGFR:30\~59 ml/min)
Mild anemia (male: Hb=110\~129 g/L; female: Hb=110\~119 g/L)
Spontaneous bleeding requiring hospitalization/transfusion within 6-12 months pre-PCI
Chronic NSAID/steroid use post-PCI
Ischemic stroke >6 months pre-PCI
Capable of understanding trial objectives and providing informed consent

Angiographic Inclusion Criteria:

Target lesion must be primary native coronary artery lesion
Target lesion with ≥70% diameter stenosis (visual estimate), or 50-70% diameter stenosis (visual estimate) with ischemic evidence
≥1 non-target lesion requiring intervention
Non-target lesions eligible for elective treatment within 1 month

Критерии исключения

General Exclusion Criteria:

Presence of ≥1 evidence of heart failure including:

NYHA Class III or higher, or
Killip classification ≥ Grade 2, or
Left ventricular ejection fraction (LVEF) ≤30% within 30 days pre-procedure (by echocardiography or intraoperative ventriculography)
Cardiogenic shock patients
Known allergies to: Aspirin / clopidogrel / ticagrelor / heparin, Contrast agents/drugs used in drug-eluting stents or contraindications to aspirin/ clopidogrel / ticagrelor
Life expectancy <12 months or factors potentially compromising clinical follow-up
Participation in other drug/medical device trials prior to enrollment without reaching primary endpoint timelines
History of substance abuse (alcohol/cocaine/heroin, etc.)
Severe arrhythmias (e.g., high-risk ventricular premature contractions/ ventricular tachycardia)
Other medical conditions deemed unsuitable by investigators

Angiographic Exclusion Criteria: