NCT07566091尚未招募不适用
Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers
Jung-min Ahn1 个研究点 分布在 1 个国家目标入组 2,034 人开始时间: 2026年10月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,034
- 试验地点
- 1
- 主要终点
- The event rate of Target Lesion Failure
研究概览
简要总结
The objective of this study is to demonstrate the primary hypothesis that, in patients with chronic and acute coronary syndromes requiring percutaneous coronary intervention (PCI), the novel sirolimus-ascorbic acid eluting stent (D+Storm Novonix) is non-inferior to the standard treatment, the everolimus-eluting stent (Synergy XD), with respect to the incidence of target lesion failure (TLF) at 1 year after treatment, where TLF is defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically driven target-lesion revascularization.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women aged 19 years or older
- •Patients with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) who require percutaneous coronary intervention (PCI) (all-comers)
- •Patients who have voluntarily provided written informed consent to participate in the study
排除标准
- •Cardiogenic shock within 48 hours prior to the procedure
- •Known hypersensitivity to sirolimus, everolimus, ascorbic acid, or stent components (e.g., cobalt-chromium alloy)
- •Patients unable to maintain dual antiplatelet therapy (DAPT), including aspirin and a P2Y12 inhibitor, for 1 year
- •Women who are pregnant, breastfeeding, or of childbearing potential who meet any of the following:
- •Have not confirmed a negative pregnancy test prior to enrollment
- •Do not agree to use, or are unlikely to maintain, an acceptable method of contraception during the study period
- •Clinically significant abnormalities identified during study visits, physical examination, laboratory tests, or electrocardiogram (ECG) that, in the investigator's judgment, may interfere with the safe completion of the study
- •Life expectancy of less than 1 year or presence of serious non-cardiac conditions that may affect compliance with the study protocol
- •Patients who are unwilling or unable to comply with the study protocol
研究组 & 干预措施
Sirolimus-Ascorbic Acid Eluting Stent
Experimental
D+STORM NOVONIX stent
干预措施: Sirolimus-Ascorbic Acid Eluting Stent (Device)
Everolimus-Eluting Stent
Active Comparator
SYNERGY XD
干预措施: Everolimus-Eluting Stent (Device)
结局指标
主要结局
The event rate of Target Lesion Failure
时间窗: 1 year
Target Lesion Failure is defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically driven target-lesion revascularization.
次要结局
- The event rate of Device success(1 year)
- The event rate of Procedural success(1 year)
- The event rate of Death from any causes(1 year)
- The event rate of Any stroke(1 year)
- The event rate of Any myocardial infarction(1 year)
- The event rate of Any repeat revascularization(1 year)
- The event rate of Cardiovascular death(1 year)
- The event rate of Target vessel myocardial infarction(1 year)
- The event rate of Target vessel revascularization(1 year)
- The event rate of All-cause death(1 year)
- The event rate of Cardiac death(1 year)
- The event rate of Non-cardiac death(1 year)
- The event rate of All myocardial infarction including Q wave and Non-Q wave(1 year)
- The event rate of Non-target vessel myocardial infarction(1 year)
- The event rate of All revascularization(1 year)
- The event rate of All target lesion revascularization(1 year)
- The event rate of All target vessel revascularization(1 year)
- The event rate of Non-target vessel revascularization(1 year)
- The event rate of Ischemic stroke(1 year)
- The event rate of Hemorrhagic stroke(1 year)
研究者
Jung-min Ahn
Professor in Department of Cardiology, Asan Medical Center
Asan Medical Center
研究点 (1)
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