REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Acandis GmbH
- 入组人数
- 153
- 试验地点
- 17
- 主要终点
- Primary Technical Efficacy Endpoint- proportion of patients with eTICI 2b-3 at the end of the treatment procedure.
研究概览
简要总结
Goal of the study is to evaluate the efficacy and safety of acute permanent stenting of symptomatic intracranial stenosis following unsuccessful recanalization by thrombectomy in acute ischemic stroke with large vessel occlusion using the self-expandable CREDO® heal Stent.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients, treated with CREDO® heal according to IFU
- •Over 18 years old
- •With acute persistent vascular occlusion due to high grade intracranial artery stenosis in the anterior or posterior circulation for which alternative therapy concepts are not considered or fail
- •With suspected underlying stenosis of the occluded artery, which is suitable for PTA and stenting according to the treating physician's assessment and/or persistent occlusion after failed recanalization by mechanical thrombectomy of the target region
- •With small to moderate infarct core prior to initiation of thrombectomy (CT ASPECTS 6-10, DWI lesion < 70 ml)
- •With symptoms onset less than 24 hours before start of the procedure
- •Treated with study device following at least one futile mechanical recanalization attempt with a stent retriever, direct aspiration or combination of both
- •With pre-stroke disability mRS 0-2
排除标准
- •Any contraindication according to IFU and patients:
- •With atherosclerotic (probable according to clinical, anamnestic or laboratory chemical testing) vessel constrictions (high-grade intracranial stenoses > 70 %) with significant circulatory disturbance (haemodynamic infarct pattern and signs of restricted collaterals) and recurrent symptoms in spite of medical therapy
- •With contraindication against treatment with anti-platelet medication
- •Participating in another trial
结局指标
主要结局
Primary Technical Efficacy Endpoint- proportion of patients with eTICI 2b-3 at the end of the treatment procedure.
时间窗: Assessed at the end of the treatment procedure.
• Technical success defined as successful recanalization of the occluded vessel (expanded treatment in cerebral ischemia score (eTICI) of 2b-3) at the end of the procedure.
Primary Clinical Efficacy Endpoint- proportion of patients with mRS 0-2 at 90 (± 20) days after procedure.
时间窗: 90 (± 20) days.
• Good clinical outcome 90 (± 20) days after stroke defined as a score of 0-2 on the modified Ranking Scale (mRS 0-2).
次要结局
未报告次要终点