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

Recruiting N/A Interventional Study
Coronary Heart Disease Acute Coronary Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
China National Center for Cardiovascular Diseases · Government
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About This Trial
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 BioFree…
Trial Locations
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Eligibility Criteria
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…
Contacts

Yongjian Wu

13701387189

fuwaiwyj@163.com

CONTACT