NCT07010965进行中（未招募）不适用
SAVE-PCI is a Prospective, Multi-center, Randomized Controlled Trial Evaluating the Safety and Efficacy of NyokAssist™ , a Small-bore Percutaneous Ventricular Assist Device (pVAD), in Comparison With Intra-aortic Balloon Pump (IABP) in Patients Undergoing Elective High-risk Percutaneous Coronary Intervention (PCI)
magAssist, Inc.12 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2024年7月31日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 236
- 试验地点
- 12
- 主要终点
- MACCE-free rate
研究概览
简要总结
SAVE-PCI is a prospective, multi-center, randomized controlled trial evaluating the safety and efficacy of NyokAssist™, a small-bore percutaneous ventricular assist device (pVAD), in comparison with intra-aortic balloon pump (IABP) in patients undergoing elective high-risk percutaneous coronary intervention (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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age eligible (18 ≤ Age ≤ 80)
- •Subject is indicated for a non-emergent percutaneous treatment of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft .
- •Patient presence at least one of the following a or b:
- •Intervention on an unprotected left main coronary artery or intervention on the last patent coronary artery .
- •Intervention on patient presenting with three-vessel* disease.
- •Three-vessel disease was defined as the presence at least one sign ficant stenosis ≥ 50% in the left anterior descending artery (LAD) and/or side branch, left circumflex artery (LCX) and/or side branch, and right coronary artery (RCA) and/or side branch. In the case of left coronary artery dominance, a lesion ≥ 50% in the proximal LAD and the LCX qualified as three-vessel disease.
- •Ejection Fraction ≤40% or Coronary rotational atherectomy or According to the assessment of the cardiac team, PCI requires hemodynamic support .
- •Volunteered to participate and Signed Informed Consent and able to cooperate with the whole trial process.
排除标准
- •Acute ST elevation Myocardial Infarction within 24 hours or CK-MB that have not normalized after acute ST elevation Myocardial Infarction.
- •Pre-procedure cardiac arrest within 24 hours of enrollment requiring CPR.
- •Subject is in cardiogenic shock defined as:
- •CI < 2.2 L/min/m2 and PCWP > 15 mmH
- •Hypotension (systolic BP < 90 mmHg for >30 minutes or the need for supportive measures to maintain a systolic BP of greater than or equal to 90 mmHg) AND end organ hypoperfusion (cool extremities OR [a urine output of < 30 mL/hour AND a HR > 60 BPM])
- •Mural thrombus in the left ventricle.
- •The presence of aortic valve replacement or mechanical circulatory support device.
- •Subject has mechanical complications of myocardial infarction.
- •Documented presence of severe aortic stenosis.
- •Documented presence of moderate to severe mitral stenosis.
- •Documented presence of severe aortic insufficiency.
- •Severe peripheral arterial obstructive disease that would preclude device placement.
- •Abnormalities of the aorta that would preclude surgery, including aortic aneurysms,aortic dissection and extreme tortuosity or calcifications.
- •Subject with renal failure (creatinine ≥265μmol/L)
- •Subject with liver dysfunction ( liver enzymes and bilirubin levels ≥3x ULN )
- •Subject has uncorrectable abnormal coagulation parameters (platelet count ≤ 75╳109 /L or fibrinogen ≤ 1.50 g/L)
- •History of recent (within 1 month) stroke or TIA .
- •Severe right ventricular dysfunction,such as severe pulmonary hypertension.
- •Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors or contrast media.
- •Subject with documented heparin induced thrombocytopenia.
- •Subject has pregnant or lactating.
- •Participation in the active follow-up phase of another clinical study of an investigational drug or device within 1 month.
- •Investigators consider unsuitable to participate in the trial.
研究组 & 干预措施
IABP Intra-aortic balloon pump
Active Comparator
干预措施: IABP Intra-aortic balloon pump (Device)
NyokAssist™
Experimental
干预措施: NyokAssist™ (Device)
结局指标
主要结局
MACCE-free rate
时间窗: Device Delivery through 30 Days
The Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Free Rate
次要结局
未报告次要终点
研究者
研究点 (12)
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