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

NCT07230847 | Not Yet Recruiting DMC

• 1 other identifier: 2025-ZX094
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (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.

  1-Month Post-Procedural Follow-Up

Secondary Outcomes (6)

• Neointimal thickness at 1-month post-procedure

  1-Month Post-Procedural Follow-Up

• Neointimal area at 1-month post-procedure

  1-Month Post-Procedure Follow-Up

• Neointimal volume at 1-month post-procedure

  1-Month Post-Procedure Follow-Up

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

  12 Months Post-Procedure

• Incidence of stent thrombosis within 12 months post-procedure

  12 Months Post-Procedure

Study Arms (2)

BioFreedom™ Drug-Coated Coronary Stent Intervention Group

EXPERIMENTAL

Device: BioFreedom™

Xience Drug-Eluting Coronary Stent System Intervention Group

ACTIVE COMPARATOR

Device: Xience

Interventions

BioFreedom™ DEVICE

BioFreedom™ Drug-Coated Coronary Stent Intervention

BioFreedom™ Drug-Coated Coronary Stent Intervention Group

Xience DEVICE

Xience Drug-Eluting Coronary Stent System Intervention

Xience Drug-Eluting Coronary Stent System Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• 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
• Left main coronary artery disease
• Bypass graft lesions
• Evidence of extensive thrombus in target vessel

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai hospital, CAMS&PUMC

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Coronary Disease; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Yongjian Wu

CONTACT

13701387189; fuwaiwyj@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: November 17, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-09

Locations

CN (1)