NCT05156996终止不适用
A Prospective Real-World Multi-Center Post-Market Observational Evaluation of Supersaturated O2 Therapy Using the TherOx® Downstream® System After PCI vs. PCI Alone Among Patients Undergoing PCI for Acute Anterior Myocardial Infarction
TherOx2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2022年12月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Measures (hierarchical) at 12-months post-procedure include rates of:
研究概览
简要总结
The purpose of this study is to collect real-world data on the TherOx DownStream System® to assess the effectiveness and cost- effectiveness of SSO2 Therapy, compared with PCI alone for treatment of patients with acute anterior MI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Men or women aged 18 years or older.
- •Presentation with anterior acute ST-elevation myocardial infarction (> 1 mm ST-segment elevation in two or more contiguous leads between V1 and V4).
- •The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery (other lesions may be treated if clinically indicated).
- •Successful angioplasty within 6 hours of symptom onset, as documented by <50% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow and no major complications such as perforation or shock.
- •The patient or their legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB).
- •Patient and his/her physician agree to all required follow-up procedures and visits.
排除标准
- •Ipsilateral insertion of a second sheath in a single femoral artery for SuperSaturated Oxygen Therapy is strictly contraindicated.
- •Presence of an intra-aortic balloon pump.
- •Proximal coronary stenosis that would restrict flow with the SSO2 Catheter in place
- •Presence of a post-intervention non-stented coronary dissection or perforation.
- •Cardiac valvular stenosis or insufficiency, pericardial disease or non-ischemic cardiomyopathy.
- •Pregnant or nursing women.
- •Cardiogenic shock.
- •Patients contraindicated for anticoagulation therapy.
- •Patients with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation (with or without papillary muscle rupture).
- •Hemoglobin < 10 g/dL.
- •Gastrointestinal or genitourinary bleeding within the last two months, or any major surgery (including CABG) within six weeks of procedure.
- •Patients with active COVID-19 infection.
结局指标
主要结局
Measures (hierarchical) at 12-months post-procedure include rates of:
时间窗: 12 months post-procedure
Rate of KCCQ-OS score at 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
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