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Coronary Heart DiseaseNCT07230847

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

A study testing BioFreedom™ and Xience in people with Coronary Heart Disease and Acute Coronary Syndrome, run by China National Center for Cardiovascular Diseases at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BioFreedom™ and Xience
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
10 Dec 2025to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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
  • Capable of understanding trial objectives and providing informed consent
  • Angiographic Inclusion Criteria:
  • Target lesion must be primary native coronary artery lesion
  • Target lesion with ≥70% diameter stenosis (visual estimate), or 50-70% diameter stenosis (visual estimate) with ischemic evidence
  • ≥1 non-target lesion requiring intervention
  • Non-target lesions eligible for elective treatment within 1 month

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yongjian Wu contact

13701387189

fuwaiwyj@163.com

China1 site, 1 recruiting

  • Fuwai hospital, CAMS&PUMC

    Beijing, Beijing Municipality, 100037

    Yongjian Wu, 13701387189, fuwaiwyj@163.com

    Recruiting

Other trials in China

About this study

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.

Being tested
BioFreedom™, Xience
Medical subject headings
Coronary Disease, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BioFreedom™Device

    BioFreedom™ Drug-Coated Coronary Stent Intervention

  • XienceDevice

    Xience Drug-Eluting Coronary Stent System Intervention

Study groups in NCT07230847
Study groupRoleWhat they receive
BioFreedom™ Drug-Coated Coronary Stent Intervention GroupExperimentalNot described
Receives: Device: BioFreedom™
Xience Drug-Eluting Coronary Stent System Intervention GroupActive comparatorNot described
Receives: Device: Xience

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OCT-Detected Neointimal Strut Coverage at 1-Month Post-Procedure

    Neointimal strut coverage was defined as:

    Covered strut proportion =Number of struts covered by neointima / Total number of analyzable struts A strut is considered covered when both its luminal surface and lateral sides demonstrate continuous neointimal tissue encapsulation.

    Measured: 1-Month Post-Procedural Follow-Up

Secondary outcomes (6)

  1. Neointimal thickness at 1-month post-procedure

    Strut neointimal thickness (NIT) will be analysed every 1 mm at 1-month post-procedure OCT follow-up

    Measured: 1-Month Post-Procedural Follow-Up

  2. Neointimal area at 1-month post-procedure

    Lumen area and stent area will be analysed every 1 mm at 1-month post-procedure OCT follow-up, neointimal area (NIA) will be calculated as stent minus lumen area.

    Measured: 1-Month Post-Procedure Follow-Up

  3. Neointimal volume at 1-month post-procedure

    Neointimal volume (NIV) and stent volume will be calculated using Simpson's rule and reported as total NIV, mean NIV (total NIV divided by length), and percent NIV (NIV divided by stent volume)

    Measured: 1-Month Post-Procedure Follow-Up

  4. Incidence of Major Adverse Cardiac Events (MACE) within 12 Months Post-Procedure

    MACE is defined as a composite of cardiac death, myocardial infarction, and target vessel revascularization (TVR).

    Measured: 12 Months Post-Procedure

  5. Incidence of stent thrombosis within 12 months post-procedure

    Stent thrombosis refers to definite or probable stent thrombosis as defined by the Academic Research Consortium (ARC) criteria

    Measured: 12 Months Post-Procedure

  6. Incidence of bleeding events within 12 months post-procedure

    bleeding events including BARC types 2, 3, or 5 bleeding.

    Measured: 12 Months Post-Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2025
  2. Study start10 Dec 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07230847
Sponsor's protocol ID
2025-ZX094
Status last verified
Sep 2025
First submitted
28 Sep 2025
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing BioFreedom™ and Xience in people with Coronary Heart Disease and Acute Coronary Syndrome, run by China National Center for Cardiovascular Diseases at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yongjian Wu (13701387189, fuwaiwyj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OCT-Detected Neointimal Strut Coverage at 1-Month Post-Procedure (time frame: 1-Month Post-Procedural Follow-Up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07230847.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026; AzTrials last refreshed its copy on 3 Nov 2026.

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