Actively Recruiting
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
Led by China National Center for Cardiovascular Diseases · Updated on 2026-04-06
60
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Male or non-pregnant female
- Acute coronary syndrome patients requiring percutaneous coronary intervention
- No contraindications for coronary artery bypass grafting
- High bleeding risk patients meeting at least 1 major or 2 minor ARC-HBR criteria
- Ability to understand trial objectives and provide informed consent
- Target lesion is primary native coronary artery lesion
- Target lesion has 70% diameter stenosis or 50-70% stenosis with ischemic evidence
- At least 1 non-target lesion requiring intervention
- Non-target lesions eligible for elective treatment within 1 month
You will not qualify if you...
- Evidence of heart failure including NYHA Class III or higher, Killip 2, or LVEF 30% within 30 days pre-procedure
- Cardiogenic shock
- Known allergies to aspirin, clopidogrel, ticagrelor, heparin, contrast agents, or contraindications to these agents
- Life expectancy less than 12 months or factors that may compromise follow-up
- Participation in other drug or device trials without completion
- History of substance abuse such as alcohol, cocaine, or heroin
- Severe arrhythmias like high-risk ventricular premature contractions or ventricular tachycardia
- Other medical conditions deemed unsuitable by the investigators
- Left main coronary artery disease
- Bypass graft lesions
- Extensive thrombus in target vessel
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fuwai hospital, CAMS&PUMC
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
Research Team
Y
Yongjian Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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