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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- OCT-Detected Neointimal Strut Coverage at 1-Month Post-Procedure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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:
- •Left main coronary artery disease
- •Bypass graft lesions
- •Evidence of extensive thrombus in target vessel
研究组 & 干预措施
BioFreedom™ Drug-Coated Coronary Stent Intervention Group
干预措施: BioFreedom™ (Device)
Xience Drug-Eluting Coronary Stent System Intervention Group
干预措施: Xience (Device)
结局指标
主要结局
OCT-Detected Neointimal Strut Coverage at 1-Month Post-Procedure
时间窗: 1-Month Post-Procedural Follow-Up
Neointimal strut coverage was defined as: Covered strut proportion =Number of struts covered by neointima / Total number of analyzable struts A strut is considered covered when both its luminal surface and lateral sides demonstrate continuous neointimal tissue encapsulation.
次要结局
- Neointimal thickness at 1-month post-procedure(1-Month Post-Procedural Follow-Up)
- Neointimal area at 1-month post-procedure(1-Month Post-Procedure Follow-Up)
- Neointimal volume at 1-month post-procedure(1-Month Post-Procedure Follow-Up)
- Incidence of Major Adverse Cardiac Events (MACE) within 12 Months Post-Procedure(12 Months Post-Procedure)
- Incidence of stent thrombosis within 12 months post-procedure(12 Months Post-Procedure)
- Incidence of bleeding events within 12 months post-procedure(12 Months Post-Procedure)