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 now · Not applicable

Conditions studied: Coronary Heart Disease, Acute Coronary Syndrome

In brief

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 facts

Study ID

NCT07230847

Run by

China National Center for Cardiovascular Diseases

People needed

60

Starts

2025-12-10

Expected to finish

2027-03-31

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years
• Male or non-pregnant female
• Acute coronary syndrome (ACS) patients requiring percutaneous coronary intervention (PCI)
• No contraindications for coronary artery bypass grafting (CABG)
• 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

You may not qualify if…

• General Exclusion Criteria:
• Presence of ≥1 evidence of heart failure including:
• NYHA Class III or higher, or
• Killip classification ≥ Grade 2, or
• Left ventricular ejection fraction (LVEF) ≤30% within 30 days pre-procedure (by echocardiography or intraoperative ventriculography)
• Cardiogenic shock patients
• Known allergies to: Aspirin / clopidogrel / ticagrelor / heparin, Contrast agents/drugs used in drug-eluting stents or contraindications to aspirin/ clopidogrel / ticagrelor
• Life expectancy <12 months or factors potentially compromising clinical follow-up
• Participation in other drug/medical device trials prior to enrollment without reaching primary endpoint timelines
• History of substance abuse (alcohol/cocaine/heroin, etc.)
• Severe arrhythmias (e.g., high-risk ventricular premature contractions/ ventricular tachycardia)
• Other medical conditions deemed unsuitable by investigators
• Angiographic Exclusion Criteria:
• Left main coronary artery disease
• Bypass graft lesions
• Evidence of extensive thrombus in target vessel

Where it is running

• Fuwai hospital, CAMS&PUMC — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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