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
Xience: Xience Drug-Eluting Coronary Stent System Intervention
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥18 years
2. Male or non-pregnant female
3. Acute coronary syndrome (ACS) patients requiring percutaneous coronary intervention (PCI)
4. No contraindications for coronary artery bypass grafting (CABG)
5. 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
6. Capable of understanding trial objectives and providing informed consent
Angiographic Inclusion Criteria:
1. Target lesion must be primary native coronary artery lesion
2. Target lesion with ≥70% diameter stenosis (visual estimate), or 50-70% diameter stenosis (visual estimate) with ischemic evidence
3. ≥1 non-target lesion requiring intervention
4. Non-target lesions eligible for elective treatment within 1 month
Exclusion Criteria:
General Exclusion Criteria:
1. 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)
2. Cardiogenic shock patients
3. Known allergies to: Aspirin / clopidogrel / ticagrelor / heparin, Contrast agents/drugs used in drug-eluting stents or contraindications to aspirin/ clopidogrel / ticagrelor
4. Life expectancy \<12 months or factors potentially compromising clinical follow-up
5. Participation in other drug/medical device trials prior to enrollment without reaching primary endpoint timelines
6. History of substance abuse (alcohol/cocaine/heroin, etc.)
7. Severe arrhythmias (e.g., high-risk ventricular premature contractions/ ventricular tachycardia)
8. Other medical conditions deemed unsuitable by investigators
Angiographic Exclusion Criteria:
1. Left main coronary artery disease
2. Bypass graft lesions
3. Evidence of extensive thrombus in target vessel
Primary outcome measure(s)
OCT-Detected Neointimal Strut Coverage at 1-Month Post-Procedure — 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.
Trial sites (1)
Facility
City
Region
Status
Fuwai hospital, CAMS&PUMC
Beijing
Beijing Municipality
Recruiting
More China National Center for Cardiovascular Diseases trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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