NCT06386289撤回不适用
Safety, Performance and Lesion Evaluation of Neurothrombectomy Using CEREGLIDE 92 Intermediate Catheter: A Prospective Multi-Center Single-Arm IDE Trial (SPLENDID)
Cerenovus, Part of DePuy Synthes Products, Inc.0 个研究点目标入组 140 人开始时间: 2025年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 140
- 主要终点
- First pass reperfusion
研究概览
简要总结
The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute ischemic stroke.
- •Baseline mRS ≤ 2
- •Completed informed consent.
排除标准
- •Known pregnancy.
- •Life expectancy less than 90 days prior to stroke onset.
- •Known Diagnosis of Dementia
- •Treatment with heparin within 48 hours.
- •Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic.
- •Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
- •Baseline CT or MRI showing mass effect
- •Concurrent sino-venous thrombosis
- •Currently participating in an investigational (drug, device, etc.) clinical trial, excluding trials in observational, natural history, and/or epidemiological studies not involving intervention and that will not confound study endpoints. Sponsor approval is required.
结局指标
主要结局
First pass reperfusion
时间窗: Intraprocedural
First pass reperfusion (eTICI ≥ 2b50 without additional therapy)
次要结局
未报告次要终点
研究者
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