One-month vessel healing after BioFreedom polymer-free drug-coated stent versus Xience drug-eluting stent in heart attack patients with high bleeding risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls acute coronary syndrome patients at high bleeding risk who receive either the BioFreedom polymer-free drug-coated stent or the Xience drug-eluting stent during PCI. Participants will undergo ultra-high-resolution optical coherence tomography (OCT) about one month after implantation to measure neointimal transformation, strut coverage, and other markers of vascular healing. The trial compares OCT-derived quantitative measures between the two stent types to characterize early healing patterns in this high-risk population. Results aim to inform stent selection and post-PCI antiplatelet strategies for patients with ACS and elevated bleeding risk.

Why it matters

Who can join: the full rules

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 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
   * Chronic NSAID/steroid use post-PCI
   * Ischemic stroke \>6 months pre-PCI
6. Capable of understanding trial objectives and providing informed consent

Angiographic Inclusion Criteria:

1. Target lesion must be primary native coronary artery lesion
2. Target lesion with ≥70% diameter stenosis (visual estimate), or 50-70% diameter stenosis (visual estimate) with ischemic evidence
3. ≥1 non-target lesion requiring intervention
4. Non-target lesions eligible for elective treatment within 1 month

Exclusion Criteria:

General Exclusion Criteria:

1. 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)
2. Cardiogenic shock patients
3. Known allergies to: Aspirin / clopidogrel / ticagrelor / heparin, Contrast agents/drugs used in drug-eluting stents or contraindications to aspirin/ clopidogrel / ticagrelor
4. Life expectancy \<12 months or factors potentially compromising clinical follow-up
5. Participation in other drug/medical device trials prior to enrollment without reaching primary endpoint timelines
6. History of substance abuse (alcohol/cocaine/heroin, etc.)
7. Severe arrhythmias (e.g., high-risk ventricular premature contractions/ ventricular tachycardia)
8. Other medical conditions deemed unsuitable by investigators

Angiographic Exclusion Criteria:

1. Left main coronary artery disease
2. Bypass graft lesions
3. Evidence of extensive thrombus in target vessel

Where it's running

• Fuwai hospital, CAMS&PUMC
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Yongjian Wu
• Email: fuwaiwyj@163.com
• Phone: 13701387189

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.