Comparison of Carbon Dioxide Flush and Saline Flush to Saline Flush Alone in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- All cause mortality
研究概览
简要总结
Thoracic endovascular repair (TEVAR) and transcatheter aortic valve implantation (TAVI) are standard of care procedures to treat thoracic aortic aneurysm or severe aortic stenosis, respectively. Both procedures have a high risk of stroke and silent infarction. Gas has been detected in the cerebral vasculature during these procedures and associated with DWI positive lesions on MRI. The hypothesis is that air emboli contribute to stroke and silent infarction. The investigators propose addressing air emboli by flushing the device with carbon dioxide prior to flushing with saline. This is a pilot study comparing standard saline flush alone to carbon dioxide flushing with saline flush.
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
- Single (Outcomes Assessor)
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
- •Elective TEVAR or TAVI
- •Over 18 years old
排除标准
- •Recent acute myocardial infarction
- •Recent stroke or TIA
- •Post or pending organ transplantation
- •Active peptic ulcer disease
- •Recent gastrointestinal bleed
- •History of bleeding diathesis or coagulopathy or contraindications to antiplatelet or anticoagulant therapy.
- •Permanent pacemaker or ICD
- •History of atrial fibrillation
- •Moderate or severe allergy to iodinated contrast not amenable to predmedication
- •Renal failure
- •Unable to safely undergo MRI
- •Enrollment in another study
结局指标
主要结局
All cause mortality
时间窗: 30 days
Post procedural death.
Complications
时间窗: 30 days
Infection, bleeding, stroke, pseudoaneurysm formation, etc.
次要结局
- Silent Infarction(7 days)
- Stroke(7 days)
研究者
Kongteng Tan
Principal Investigator
University Health Network, Toronto