Coronary Heart Disease, Acute Coronary Syndrome
Conditions
Brief 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.
Interventions
DEVICEBioFreedom™
BioFreedom™ Drug-Coated Coronary Stent Intervention
DEVICEXience
Xience Drug-Eluting Coronary Stent System Intervention
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neointimal area at 1-month post-procedure | 1-Month Post-Procedure Follow-Up | Lumen area and stent area will be analysed every 1 mm at 1-month post-procedure OCT follow-up, neointimal area (NIA) will be calculated as stent minus lumen area. |
| Neointimal volume at 1-month post-procedure | 1-Month Post-Procedure Follow-Up | Neointimal volume (NIV) and stent volume will be calculated using Simpson's rule and reported as total NIV, mean NIV (total NIV divided by length), and percent NIV (NIV divided by stent volume) |
| Neointimal thickness at 1-month post-procedure | 1-Month Post-Procedural Follow-Up | Strut neointimal thickness (NIT) will be analysed every 1 mm at 1-month post-procedure OCT follow-up |
| Incidence of stent thrombosis within 12 months post-procedure | 12 Months Post-Procedure | Stent thrombosis refers to definite or probable stent thrombosis as defined by the Academic Research Consortium (ARC) criteria |
| Incidence of bleeding events within 12 months post-procedure | 12 Months Post-Procedure | bleeding events including BARC types 2, 3, or 5 bleeding. |
| Incidence of Major Adverse Cardiac Events (MACE) within 12 Months Post-Procedure | 12 Months Post-Procedure | MACE is defined as a composite of cardiac death, myocardial infarction, and target vessel revascularization (TVR). |
Countries
China
Contacts
Primary ContactYongjian Wu
Outcome results
None listed