Asian Registry of the BioFreedom Stent for STEMI Patients

Completed

• Conditions: STEMI - ST Elevation Myocardial Infarction
• Interventions: Device: PCI

• Registration Number: NCT03609346
• Lead Sponsor: Biosensors Europe SA

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.

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 Timeline

• Study First Submitted: 2018-07-25
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-01
• Study Start: 2018-11-22
• Primary Completion: 2022-01-30
• Study Completion: 2022-08-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 914

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	12 months	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).

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Seoul National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of

Her Majesty Cardiac Centre; 🇹🇭 Bangkok, Thailand

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan