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

NCT ID: NCT07230847

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-03-31

Brief 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. 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.

Conditions

Coronary Heart Disease; Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BioFreedom™ Drug-Coated Coronary Stent Intervention Group

Group Type: EXPERIMENTAL

BioFreedom™

Intervention Type: DEVICE

BioFreedom™ Drug-Coated Coronary Stent Intervention

Xience Drug-Eluting Coronary Stent System Intervention Group

Group Type: ACTIVE_COMPARATOR

Xience

Intervention Type: DEVICE

Xience Drug-Eluting Coronary Stent System Intervention

Interventions

BioFreedom™

BioFreedom™ Drug-Coated Coronary Stent Intervention

Intervention Type: DEVICE

Xience

Xience Drug-Eluting Coronary Stent System Intervention

Intervention Type: DEVICE

Eligibility Criteria

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

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

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

1. Left main coronary artery disease

2. Bypass graft lesions

3. Evidence of extensive thrombus in target vessel

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fuwai hospital, CAMS&PUMC

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Yongjian Wu

Role: CONTACT

fuwaiwyj@163.com

13701387189

Facility Contacts

Yongjian Wu

Role: primary

fuwaiwyj@163.com

13701387189

Other Identifiers

2025-ZX094

Identifier Type: -

Identifier Source: org_study_id