Stroke Process in FEmoral Versus Radial Access
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- No inferiority of radial access in the recanalization rate
研究概览
简要总结
In patients with suspected acute stroke due to large vessel occlusion with indication for endovascular treatment, radial access is just as safe, fast, and effective as femoral access, and it improves the entire stroke treatment process.
详细描述
Investigators will compare the procedure times, angiographic results as well as the clinical evolution and the patient's experience during their hospital stay and after discharge, depending on the arterial access practiced for mechanical thrombectomy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with high suspicion of ischemic stroke due to large cerebral vessel occlusion defined by NIHSS>
- •Immediate availability of the entire team responsible for endovascular treatment (Neurologist, Neurointerventional physician, Anesthetist, Nursing, Technicians ...)
- •Radial artery diameter ≥2.5 mm
- •Presence of femoral pulse or patency by ultrasonography in its defect.
- •Previous functional independence (mRS 0-2).
排除标准
- •Life expectancy of less than 6 months.
- •Intracranial hemorrhage
- •Patients with pre-existing neurological or psychiatric pathology that may confuse future evaluations.
- •No availability for follow-up after 90 days.
结局指标
主要结局
No inferiority of radial access in the recanalization rate
时间窗: Immediate after treatment
To demonstrate the non-inferiority of radial access with respect to femoral access in the recanalization rate (% mTICI 2b-3 in 3 or fewer passes) obtained in patients with large vessel occlusion treated by mechanical thrombectomy.
次要结局
- Change of artery access(24 hours)
- Grades of modified Thrombolysis in Cerebral Infarction(24 hours)
- Times during hospitalization(At 24 hours and during first 5 days)
- No differences in complications in vascular access(24 hours)
- Patient Reported Outcomes(5 days)
- Patient experience(5 days)
- Degree of disability/dependence after a stroke(24 hours and at 90 days)