Asian Registry of the BioFreedom Stent for STEMI Patients

STEMI - ST Elevation Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03609346
• Other study ID #: 18-APAC-01
• Status: Completed
• Start date: November 22, 2018
• Est. completion date: August 5, 2022

Study information

• Verified date: February 2024
• Source: Biosensors Europe SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 914
• Est. completion date: August 5, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Biosensors Europe SA	Biosensors Interventional Technologies Pte Ltd

Countries where clinical trial is conducted

Hong Kong,  Korea, Republic of,  Singapore,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1. All-cause mortality	1. All-cause mortality	12 months
Secondary	2. Cardiovascular death	2. Cardiovascular death (cardiovascular and undetermined)	12 months
Secondary	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
Secondary	4. Stroke disabling and non-disabling ARC definition	4. Stroke disabling and non-disabling ARC definition	12 months
Secondary	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
Secondary	6. ARC2 ST	6. ARC2 ST	12 months
Secondary	7. Clinically driven TLR at any follow-up time point	7. Clinically driven TLR at any follow-up time point	12 months
Secondary	8. Clinically driven target vessel revascularization	8. Clinically driven target vessel revascularization	12 months
Secondary	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
Secondary	10. Bleeding per BARC criteria a. BARC 3 to 5	10. Bleeding per BARC criteria; a. BARC 3 to 5	12 months