Total Cerebral Protection With Embolic Protection Devices in Thoracic Aortic Stenting
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of brain injury assessed by Magnetic resonance imaging (MRI) test
研究概览
简要总结
Stroke and silent cerebral infarction are a real risk with thoracic enodvascular aortic repair (TEVAR). The investigator propose to prospectively observational study with enrolment of all patients undergoing TEVAR for thoracic and thoracoabdominal conditions including aneurysmal degeneration, Type B dissection and acute aortic syndromes over a 24 month period, equating to a minimum of 20-30 patients per year. Patients undergoing juxtra-renal and infra-renal aortic stenting will form a control group.
详细描述
TEVAR involves the insertion of a stent into the thoracic aorta to re-line it and prevent life-threatening haemorrhage from rupture, and ultimately death. The stent is inserted through a small cut in the femoral artery in the groin that is able to track to the desired location in the thoracic aorta over wires. The thoracic aorta and the branches it provides to supply the brain are diseased with atherosclerotic plaques and thrombus. The manipulation of wires and stents over these diseased locations can lead to small fragments breaking off and travelling to the brain to block the blood supply to areas of the brain (cerebral embolisation).
Cerebral embolic protection devices (CEPDs) consist of filters that can be placed into the branches of the thoracic aorta that supply the brain(supra-aortic branches) before TEVAR and can capture and remove solid debris, preventing it from reaching the brain.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients requiring TEVAR as decided upon by a multidisciplinary meeting
排除标准
- •Contraindication to MRI scanning
- •Unable to give consent
结局指标
主要结局
Incidence of brain injury assessed by Magnetic resonance imaging (MRI) test
时间窗: Pre-operative and post-operative up to 6 months
Magnetic resonance imaging (MRI) of the brain is a safe and painless test that uses a magnetic field and radio waves to produce detailed images of the brain.
次要结局
- Incidence of embolic event(Intra-operative)
- Changes in neurocognition function(Pre-operative and post-operative up until 6 months)