Asian Registry of the BioFreedom™ BA9™ Drug-Coated Coronary Stent for Patients With ST Elevation Myocardial Infarction (STEMI) Undergoing Percutaneous Coronary Intervention (PCI)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- STEMI - ST Elevation Myocardial Infarction
- Sponsor
- Biosensors Europe SA
- Enrollment
- 914
- Locations
- 5
- Primary Endpoint
- Target Lesion Failure (TLF)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Target Lesion Failure (TLF)
Time Frame: 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 Outcomes
- 10. Bleeding per BARC criteria a. BARC 3 to 5(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)
- 6. ARC2 ST(12 months)
- 5. Myocardial infarction (according to the Third Universal Definition) a. Q wave, non-Q wave and all myocardial infarctions(12 months)
- 7. Clinically driven TLR at any follow-up time point(12 months)
- 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(12 months)
- 1. All-cause mortality(12 months)
- 2. Cardiovascular death(12 months)