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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
Sponsor: China National Center for Cardiovascular Diseases
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-12-10
Completion Date
2027-03-31
Last Updated
2026-04-06
Healthy Volunteers
No
Interventions
BioFreedom™
BioFreedom™ Drug-Coated Coronary Stent Intervention
Xience
Xience Drug-Eluting Coronary Stent System Intervention
Locations (1)
Fuwai hospital, CAMS&PUMC
Beijing, Beijing Municipality, China