Actively Recruiting
Evaluating Vascular Healing and Neointimal Transformation at 1 Month After BioFreedom22 Drug-Coated Stent and Xience Drug-Eluting Stent Implantation in Acute Coronary Syndrome Patients with 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
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the vascular healing and neointimal transformation after implantation of two types of coronary stents in patients with acute coronary syndrome (ACS) who also have a high risk of bleeding. The study compares the BioFreedom22 polymer-free drug-coated stent, designed to reduce inflammation and promote early healing, with the Xience drug-eluting stent system. The goal is to better understand the healing patterns and safety of these stents using advanced optical coherence tomography (OCT) imaging. Participants will be randomly assigned to receive either the BioFreedom22 drug-coated stent or the Xience drug-eluting stent during their percutaneous coronary intervention. The key focus is on the stent's neointimal strut coverage and transformation one month after implantation. The study uses high-resolution OCT to assess these outcomes, providing detailed information on how each device performs in the early healing phase. During the study, patients will undergo OCT imaging at one month post-procedure to measure neointimal strut coverage, thickness, area, and volume. Researchers will also monitor the incidence of major adverse cardiac events, stent thrombosis, and bleeding events over a 12-month period. Participants will be followed closely to evaluate the safety and efficacy of the stents, with total involvement lasting at least one year after their procedure.
CONDITIONS
Brief 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
- Diagnosed with acute coronary syndrome and require percutaneous coronary intervention
- No contraindications for coronary artery bypass grafting
- High bleeding risk according to ARC-HBR definition (at least 1 major or 2 minor criteria)
- Able to understand trial objectives and provide informed consent
- Target lesion is primary native coronary artery lesion with 50% or more diameter narrowing or 50-70% with ischemic evidence
- At least one non-target lesion requiring intervention
- Non-target lesions eligible for elective treatment within 1 month
You will not qualify if you...
- Heart failure with NYHA Class III or higher, Killip grade 2 or above, or left ventricular ejection fraction under 30% within 30 days before procedure
- Cardiogenic shock
- Allergies to aspirin, clopidogrel, ticagrelor, heparin, contrast agents, or contraindications to these medications
- Life expectancy less than 12 months or factors compromising follow-up
- Participation in other drug or device trials without reaching primary endpoint timelines
- History of substance abuse
- Severe arrhythmias such as high-risk ventricular premature contractions or ventricular tachycardia
- Other medical conditions deemed unsuitable by investigators
- Left main coronary artery disease
- Bypass graft lesions
- Extensive thrombus in target vessel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo implantation of either the BioFreedom™ Drug-Coated Coronary Stent or the Xience Drug-Eluting Coronary Stent System as treatment for acute coronary syndrome with high bleeding risk.
1 procedure visit (in-person)
Duration - 1 month post-procedure
Participants are monitored for vascular healing and neointimal transformation using Optical Coherence Tomography at 1 month post-implantation.
1 follow-up visit (in-person)
Duration - Up to 12 months post-procedure
Participants are observed for incidence of major adverse cardiac events, stent thrombosis, and bleeding events for up to 12 months after the procedure.
Visits as scheduled over 12 months
Trial Site Locations
Total: 1 location
1
Fuwai hospital, CAMS&PUMC
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
Research Team
Y
Yongjian Wu
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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