Asian Registry of the BioFreedom™ BA9™ Drug-Coated Coronary Stent for Patients With ST Elevation Myocardial Infarction (STEMI) Undergoing Percutaneous Coronary Intervention (PCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 914
- 试验地点
- 5
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 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).
次要结局
- 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)