Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers (NOVA)
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jung-hee Ham Project Manager, Registered Nurse
- 电话号码：82-2-3010-4728
- 邮箱：cvcrc5@amc.seoul.kr
学习地点
-
-
-
Seoul、韩国
- 招聘中
- Asan Medical Center
-
接触：
- Jung-min Ahn, MD
- 电话号码：82-2-3010-4728
- 邮箱：cvcrc5@amc.seoul.kr
-
首席研究员：
- Jung-min Ahn, MD, PhD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
-
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Sirolimus-Ascorbic Acid Eluting Stent
D+STORM NOVONIX stent |
bioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent |
|
有源比较器：Everolimus-Eluting Stent
SYNERGY XD |
bioabsorbable polymer everolimus-eluting stent |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The event rate of Target Lesion Failure
大体时间：1 year
|
Target Lesion Failure is defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically driven target-lesion revascularization. |
1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The event rate of Device success
大体时间：1 year
|
Acute Success Endpoints_lesion level |
1 year
|
|
The event rate of Procedural success
大体时间：1 year
|
Acute Success Endpoints_patient level |
1 year
|
|
The event rate of Death from any causes
大体时间：1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Any stroke
大体时间：1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Any myocardial infarction
大体时间：1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Any repeat revascularization
大体时间：1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Cardiovascular death
大体时间：1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure |
1 year
|
|
The event rate of Target vessel myocardial infarction
大体时间：1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure |
1 year
|
|
The event rate of Target vessel revascularization
大体时间：1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure |
1 year
|
|
The event rate of All-cause death
大体时间：1 year
|
Individual Clinical Endpoints_Mortality |
1 year
|
|
The event rate of Cardiac death
大体时间：1 year
|
Individual Clinical Endpoints_Mortality |
1 year
|
|
The event rate of Non-cardiac death
大体时间：1 year
|
Individual Clinical Endpoints_Mortality |
1 year
|
|
The event rate of All myocardial infarction including Q wave and Non-Q wave
大体时间：1 year
|
Individual Clinical Endpoints_Myocardial Infarction |
1 year
|
|
The event rate of Non-target vessel myocardial infarction
大体时间：1 year
|
Individual Clinical Endpoints_Myocardial Infarction |
1 year
|
|
The event rate of All revascularization
大体时间：1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of All target lesion revascularization
大体时间：1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of All target vessel revascularization
大体时间：1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of Non-target vessel revascularization
大体时间：1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of Any stroke
大体时间：1 year
|
Individual Clinical Endpoints_Stroke |
1 year
|
|
The event rate of Ischemic stroke
大体时间：1 year
|
Individual Clinical Endpoints_Stroke |
1 year
|
|
The event rate of Hemorrhagic stroke
大体时间：1 year
|
Individual Clinical Endpoints_Stroke |
1 year
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The event rate of Definite or probable stent thrombosis
大体时间：1 year
|
Safety Endpoints |
1 year
|
|
The event rate of Definite stent thrombosis
大体时间：1 year
|
Safety Endpoints |
1 year
|
|
The event rate of Probable stent thrombosis
大体时间：1 year
|
Safety Endpoints |
1 year
|
|
The event rate of The Bleeding Academic Research Consortium (BARC) type 2, 3, 4, 5
大体时间：1 year
|
Safety Endpoints |
1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- AMCCV 2026-02
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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