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
China National Center for Cardiovascular Diseases
60 participants
Dec 10, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria32
- 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
- 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
Exclusion Criteria14
- 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
- Left main coronary artery disease
- Bypass graft lesions
- Evidence of extensive thrombus in target vessel
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Interventions
BioFreedom™ Drug-Coated Coronary Stent Intervention
Xience Drug-Eluting Coronary Stent System Intervention
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07230847