NCT05305482

Brief Summary

To test whether the polymer-free drug-coated stent (DCS) BioFreedom is noninferior to the biodegradable polymer drug-eluting stent (DES) Ultimaster in terms of 1-year patient-oriented composite endpoint (POCE, composite of all-cause mortality, any MI, or any revascularization) in a setting of 1-month dual-antiplatelet therapy (DAPT) strategy (1-month DAPT followed ticagrelor monotherapy) after acute coronary syndrome.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,520

participants targeted

Target at P75+ for not_applicable

Timeline
46mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Aug 2022Feb 2030

First Submitted

Initial submission to the registry

March 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

August 10, 2022

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2030

Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

7.5 years

First QC Date

March 22, 2022

Last Update Submit

May 18, 2025

Conditions

Acute Coronary Syndrome

Keywords

Acute coronary syndromeDrug-eluting stentDual-antiplatelet therapyTicagrelor

Outcome Measures

Primary Outcomes (1)

  • Patient-Oriented Composite Endpoint (POCE)

    The composite of all-cause death, MI, or any revascularization

    At 1 year after randomization

Secondary Outcomes (12)

  • Device-Oriented Composite Endpoint (DOCE)

    At 1 year after randomization

  • All-cause death

    At 1 year after randomization

  • Cardiovascular death

    At 1 year after randomization

  • Myocardial infarction

    At 1 year after randomization

  • Stroke

    At 1 year after randomization

  • +7 more secondary outcomes

Study Arms (2)

DCS group

EXPERIMENTAL

Drug-coated stent group

Device: Drug-coated stent

DES group

ACTIVE COMPARATOR

Drug-eluting stent group

Device: Drug-eluting stent

Interventions

Drug-coated stentDEVICE

The polymer-free drug-coated stent (BioFreedom Ultra stent) will be implanted for the DCS group.

Also known as: BioFreedom Ultra stent
DCS group
Drug-eluting stentDEVICE

The Biodegradable polymer drug-eluting stent (Ultimaster stent) will be implanted for the DES group.

Also known as: Ultimaster stent
DES group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥19 years
  • All subjects who are acceptable candidates for treatment with a drug-coated stent or drug-eluting stent because of acute coronary syndrome
  • Provision of informed consent

You may not qualify if:

  • Current or potential pregnancy
  • Need of oral anticoagulation therapy
  • Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Chul-Min Ahn

    Yonsei University Health System, Severance Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chul-Min Ahn

CONTACT

+82-2-2228-8532drcello@yuhs.ac

Sung-Jin Hong, MD, PhD

CONTACT

+82-2-2228-8452hongs@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Principal Investigator

Study Record Dates

First Submitted

March 22, 2022

First Posted

March 31, 2022

Study Start

August 10, 2022

Primary Completion (Estimated)

February 14, 2030

Study Completion (Estimated)

February 14, 2030

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

The data will be available from the principal investigator on reasonable request.

Locations

KR(1)