Asian Registry of the BioFreedom Stent for STEMI Patients

Asian Registry of the BioFreedom™ BA9™ Drug-Coated Coronary Stent for Patients With ST Elevation Myocardial Infarction (STEMI) Undergoing Percutaneous Coronary Intervention (PCI)

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.

Study Overview

• Status: Completed
• Conditions: STEMI - ST Elevation Myocardial Infarction
• Intervention / Treatment: Device: PCI

Detailed Description

The purpose of this registry is to assess the safety and efficacy of the BioFreedom stent for treatment of STEMI patients. The objective is to capture patients' outcomes and antithrombotic strategies data using one or several BioFreedom Stents in the routine treatment of STEMI patients. This will be a fully observational post market registry designed to enroll 1000 STEMI patients at about 20 centers in up to 8 Asian countries where the BioFreedom BA9 (SS) DCS is available for clinical use.

The primary endpoint is LTF, which is a composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization.

The investigators expect event rates of the composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization to be 4.3% at one year as observed in the COMFORTABLE AMI study. Assuming a one-sided type I error (α) of 0.025, and a non-inferiority margin of 1.9%, a cohort of 1000 patients will have more than 80% power to conclude non-inferiority. The complete data analysis will be described in a Statistical Analysis Plan (SAP) that will be finalized and signed before the one year database lock.

Primary and secondary endpoint related events will be adjudicated by independent adjudicators. The study will be monitored per a monitoring plan, data will be collected in an electronic data capture system.

All enrolled patients will be followed up at 1, 4 and 12 months to collect information on their current status, review of cardiac medication taken and any adverse events that they have experienced.

Both CERC and Biosensors will follow company SOP's which are GCP and ISO 14155:2011 compliant.

• Study Type: Observational
• Enrollment (Actual): 914

Contacts and Locations

• Study Contact: Name: Jolanda de Groot, MSc; Phone Number: +31652832955; Email: j.degroot@biosensors.com
• Study Contact Backup: Name: Dervilla Bermingham, MSc; Phone Number: +41798275582; Email: d.bermingham@biosensors.com

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Bundang Hospital
• Singapore
  • Singapore, Singapore
    • Tan Tock Seng Hospital
• Taiwan
  • Taipei, Taiwan
    • Mackay Memorial Hospital
• Thailand
  • Bangkok, Thailand
    • Her Majesty Cardiac Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
STEMI; Arm: STEMI Intervention: PCI with 1 or more BioFreedom stents in patients presenting with a STEMI. Medication according to hospital practice.	Device: PCI; The placement of 1 or more stents in the diseased coronary artery lesion(s).; Other Names: Revascularization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. All-cause mortality	1. All-cause mortality	12 months
2. Cardiovascular death	2. Cardiovascular death (cardiovascular and undetermined)	12 months
3. The composite of cardiac death, Target Lesion (TL)-related myocardial infarction and TL-related definite or probable stent thrombosis	3. The composite of cardiac death, Target Lesion (TL)-related myocardial infarction and TL-related definite or probable stent thrombosis at one year	12 months
4. Stroke disabling and non-disabling ARC definition	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	5. Myocardial infarction (according to the Third Universal Definition) a. Q wave, non-Q wave and all myocardial infarctions	12 months
6. ARC2 ST	6. ARC2 ST	12 months
7. Clinically driven TLR at any follow-up time point	7. Clinically driven TLR at any follow-up time point	12 months
8. Clinically driven target vessel revascularization	8. Clinically driven target vessel revascularization	12 months
9. Any revascularization within 12 months following the index procedure, unless they are planned within the 1st month	9. Any revascularization within 12 months following the index procedure, unless they are planned within the 1st month	12 months
10. Bleeding per BARC criteria a. BARC 3 to 5	10. Bleeding per BARC criteria a. BARC 3 to 5	12 months

Collaborators and Investigators

• Sponsor: Biosensors Europe SA
• Collaborators: Biosensors Interventional Technologies Pte Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2018
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): August 5, 2022

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: STEMI
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: 18-APAC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No