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

March 31, 2026 updated by: China National Center for Cardiovascular Diseases
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100037
        • Recruiting
        • Fuwai Hospital, CAMS&PUMC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BioFreedom™ Drug-Coated Coronary Stent Intervention Group
Device: BioFreedom™
BioFreedom™ Drug-Coated Coronary Stent Intervention
Active Comparator: Xience Drug-Eluting Coronary Stent System Intervention Group
Device: Xience
Xience Drug-Eluting Coronary Stent System Intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
OCT-Detected Neointimal Strut Coverage at 1-Month Post-Procedure
Time Frame: 1-Month Post-Procedural Follow-Up

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.
1-Month Post-Procedural Follow-Up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neointimal thickness at 1-month post-procedure
Time Frame: 1-Month Post-Procedural Follow-Up
Strut neointimal thickness (NIT) will be analysed every 1 mm at 1-month post-procedure OCT follow-up
1-Month Post-Procedural Follow-Up
Neointimal area at 1-month post-procedure
Time Frame: 1-Month Post-Procedure Follow-Up
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.
1-Month Post-Procedure Follow-Up
Neointimal volume at 1-month post-procedure
Time Frame: 1-Month Post-Procedure Follow-Up
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)
1-Month Post-Procedure Follow-Up
Incidence of Major Adverse Cardiac Events (MACE) within 12 Months Post-Procedure
Time Frame: 12 Months Post-Procedure
MACE is defined as a composite of cardiac death, myocardial infarction, and target vessel revascularization (TVR).
12 Months Post-Procedure
Incidence of stent thrombosis within 12 months post-procedure
Time Frame: 12 Months Post-Procedure
Stent thrombosis refers to definite or probable stent thrombosis as defined by the Academic Research Consortium (ARC) criteria
12 Months Post-Procedure
Incidence of bleeding events within 12 months post-procedure
Time Frame: 12 Months Post-Procedure
bleeding events including BARC types 2, 3, or 5 bleeding.
12 Months Post-Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Center for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-ZX094

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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