NCT03609346

Brief Summary

The BioFreedom BA9 (Stainless Steel) Drug Coated Stent is an approved stent that is already commercially available in Europe and Asia. The purpose of this registry is to assess the safety and efficacy of the BioFreedom stent for treatment of a specific group of patients; patients with a myocardial infarction (STEMI). The objective is to capture patients' outcomes and antithrombotic strategies data using one or several BioFreedom Stents in the routine treatment of these STEMI patients.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
914

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
5 countries

5 active sites

Status
completed

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

First Submitted

Initial submission to the registry

July 25, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 22, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

3.2 years

First QC Date

July 25, 2018

Last Update Submit

February 28, 2024

Conditions

STEMI - ST Elevation Myocardial Infarction

Keywords

STEMI

Outcome Measures

Primary Outcomes (1)

  • Target Lesion Failure (TLF)

    TLF (Target Lesion Failure) defined as composite of cardiovascular death, target-vessel related myocardial infarction (Q-wave and non-Q-wave), or ischemia-driven target lesion revascularization within 12 months (device-oriented outcome per ARC2 definitions).

    12 months

Secondary Outcomes (10)

  • 1. All-cause mortality

    12 months

  • 2. Cardiovascular death

    12 months

  • 3. The composite of cardiac death, Target Lesion (TL)-related myocardial infarction and TL-related definite or probable stent thrombosis

    12 months

  • 4. Stroke disabling and non-disabling ARC definition

    12 months

  • 5. Myocardial infarction (according to the Third Universal Definition) a. Q wave, non-Q wave and all myocardial infarctions

    12 months

  • +5 more secondary outcomes

Study Arms (1)

STEMI

Arm: STEMI Intervention: PCI with 1 or more BioFreedom stents in patients presenting with a STEMI. Medication according to hospital practice.

Device: PCI

Interventions

PCIDEVICE

The placement of 1 or more stents in the diseased coronary artery lesion(s).

Also known as: Revascularization
STEMI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The registry is open to all patients presenting with STEMI and treated with one or more BioFreedom BA9 (SS) DCS.

You may qualify if:

  • STEMI patients treated with one or several BioFreedom stent(s) within 12h of symptom onset
  • Patients who agree to comply with the follow up requirements.
  • Patients with a life expectancy of \> 1 year at time of consent.
  • Patients eligible to receive dual anti platelet therapy (DAPT). The establishment of the DAPT regimen is at the physician's discretion.

You may not qualify if:

  • Patients in cardiogenic shock
  • Any out of hospital cardiac arrest
  • Glasgow score \< 15
  • Patients unable or unwilling to give documented informed consent
  • Patients with any PCI 6 months prior to the baseline procedure
  • Patients taking part in another interventional trial which has not completed follow-up for the primary endpoint
  • Patient has received an additional stent different from a BioFreedomBA9 (SS) DCS stent during the index procedure.
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Tan Tock Seng Hospital

Singapore, Singapore

Location

Seoul National University Bundang Hospital

Seoul, South Korea

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

Her Majesty Cardiac Centre

Bangkok, Thailand

Location

Related Publications (1)

  • Ong PJL, Chui SF, Tam FC, Nguyen QT, Tsai CT, Kang WC, Nuruddin AA, Singh R, Chotinaiwattarakul C, Lee M. Polymer free biolimus coated stents to treat acute ST-elevation myocardial infarction in Asian patients. Catheter Cardiovasc Interv. 2024 Dec;104(7):1406-1413. doi: 10.1002/ccd.31263. Epub 2024 Oct 21.

    PMID: 39434554DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 1, 2018

Study Start

November 22, 2018

Primary Completion

January 30, 2022

Study Completion

August 5, 2022

Last Updated

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)TH(1)SG(1)HK(1)KR(1)