Comparison of a Contemporary Sirolimus-eluting Stent (ihtDEStiny®) With Another Everolimus-eluting Stent (Xience™), Both With Permanent Polymers, in Patients With Acute Coronary Syndrome and de Novo Coronary Artery Lesions (DestinACSion Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,100
- 试验地点
- 23
- 主要终点
- EFFICACY: Device-oriented Composite Endpoint (DoCE)
研究概览
简要总结
To evaluate the efficacy of the two DES (Drug Eluting Stent) used in terms of device-related adverse events at 12 months after PCI (Percutaneous Coronary Intervention).
To compare the clinical safety and efficacy by comparing net clinical events (defined as the combination of ischemic and hemorrhagic events) of the two DES used at 12 months after PCI.
详细描述
To evaluate the efficacy of the two DES (Drug Eluting Stent) used in terms of device-related adverse events at 12 months after PCI (Percutaneous Coronary Intervention).
To compare the clinical safety and efficacy by comparing net clinical events (defined as the combination of ischemic and hemorrhagic events) of the two DES used at 12 months after PCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet ALL inclusion criteria will be included:
- •Patients aged ≥18 years, and
- •Patients diagnosed with an acute coronary syndrome (ACS), either SCASEST (Acute Coronary Syndrome without Persistent ST-Segment Elevation) or IAMCEST (Acute Myocardial Infarction with Persistent ST-Segment Elevation), for which they will undergo PCI, and
- •Patients with de novo lesions in vessels with a reference diameter of ≥2.25 mm and ≤4.5 mm in whom implantation of one or more DES is clinically indicated, and
- •Patients who have been informed of the characteristics of the study and have provided written informed consent.
排除标准
- •Patients must not meet any of the following exclusion criteria:
- •Patients in cardiogenic shock according to the severity criteria defined by the Society of Cardiovascular Angiography and Interventions (SCAI): "C" (Classic Shock), "D" (Deteriorating) and "E" (Extremis).
- •Patients unable to provide informed consent.
- •Patients with a known hypersensitivity or allergy to aspirin or any P2Y12 receptor inhibitor (clopidogrel, prasugrel, ticagrelor), heparin, contrast agents, or any of the components of DES.
- •Patients with active bleeding at the time of PCI requiring medical attention.
- •Patients with planned surgery within the next 3 months.
- •Patients with any medical condition that limits a life expectancy of less than 12 months.
- •Patients participating in another clinical trial in which the primary endpoint was not met.
- •Pregnant or breastfeeding women of childbearing potential with a positive pregnancy test.
研究组 & 干预措施
Experimental: Xience™ DES
干预措施: Xience™ DES implanted (Device)
Active Comparator: ihtDEStiny® DES
干预措施: ihtDEStiny® DES implanted (Device)
结局指标
主要结局
EFFICACY: Device-oriented Composite Endpoint (DoCE)
时间窗: 12 months
Composite clinical endpoint cardiac Rate at 12 months cause death, target vessel myocardial infraction (TV-MI), and Clinically individual target lesion revascularization (CI-TLR)
NACE
时间窗: 12 months
Composite clinical endpoint Rate of all-cause death, any stroke, any MI, any revascularization and BARC type 3 or 5 bleeding events
次要结局
- Target Vessel Revascularization Rate (TVR) at 24 months(24 months)
- Definite/Probable stent thrombosis rate at 24 months(24 months)
- All-Cause Death Rate at 12 months(12 months)
- All-Cause Death Rate at 24 months(12 months)
- Cardiac Death Rate at 12 months(12 months)
- Cardiac Death Rate at 24 months(12 months)
- Periprocedural myocardial infarction Rate(PCI procedure)
- Myocardial Infarction Rate at 12 months(12 months)
- Myocardial Infarction Rate at 24 months(12 months)
- Definite/Probable stent thrombosis rate at 12 months(12 months)
- Any stroke at 12 months(12 months)
- Any stroke at 24 months(12 months)
- BARC type 2 ,3 or 5 bleeding events at 12 months(12 months)
- BARC type 2 ,3 or 5 bleeding events at 24 months(24 months)
- Target vessel revascularization Rate at 12 months(12 months)
- Target vessel revascularization Rate at 24 months(24 months)
- Target vessel Failure (TVF) Rate at 12 months(12 months)
- Target vessel Failure (TVF) Rate at 24 months(24 months)
- Target Lesion Failure (TLF) Rate at 12 months(12 months)
- Target Lesion Failure (TLF) Rate at 24 months(24 months)
- Target Vessel Revascularization Rate (TVR) at 12 months(12 months)
- Target lesion ischemia-guided revascularization Rate at 12 months(12 months)
- Target lesion ischemia-guided revascularization Rate at 24 months(24 months)
- Repeated revascularization Rate at 12 months(12 months)
- Repeated revascularization Rate at 24 months(24 months)
- Major Adverse Cardiac Events (MACE) Rate at 12 months(12 months)
- Major Adverse Cardiac Events (MACE) Rate at 24 months(24 months)