Safety and Tolerability of Local Ischemic Post-conditioning in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of participants with major response
研究概览
简要总结
Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. The purpose of this proof-of-concept study is to determine the safety and tolerability of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 18-80 years;
- •Acute ischemic stroke caused by middle cerebral artery M1 segment occlusion;
- •Successful recanalization (mTICI 2b/3) after endovascular thrombectomy that confirmed by digital subtraction angiography;
- •Written informed consent provided by the patients or their legal relatives.
排除标准
- •Known diagnosis or clinical suspicion of cerebral vasculitis or fibromuscular dysplasia;
- •Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
- •Stenting in the middle cerebral artery as rescue therapy during the thrombectomy procedures;
- •> 2 times of balloon dilations as rescue therapy due to angioplasty during the thrombectomy procedures;
- •Moderate or severe residual stenosis (≥ 50%) of the culprit artery after recanalization;
- •Difficulty in complying with ischemic post-conditioning or other conditions that the investigator considered inappropriate for inclusion.
结局指标
主要结局
Number of participants with major response
时间窗: Immediately after intervention on the day of ischemic post-conditioning
Major response is any of the following: * Vessel perforation or rupture; * Reocclusion of the culprit vessel after post-conditioning; * Vessel dissection; * Severe vasospasm; * Ischemic post-conditioning related thrombotic events; * Rupture of the balloon used for post-conditioning. In the 3 + 3 design, 3 subjects are recruited for a given ischemic post-conditioning dose level. The trial is stopped if ≥ 2 of 3 subjects at a given dose level show major response. If only 1 of 3 subjects shows major response, 3 more subjects are recruited at a given dose level and a major response in any of them will stop the trial. Otherwise, same procedure is followed for the next ischemic post-conditioning dose level. Maximum tolerable dose will be the dose at the level before stopping of the trial.
次要结局
未报告次要终点
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University