NCT07367100招募中不适用
A Prospective, First in Human Pivotal Study to Evaluate the Adaptive Tip Catheter Used to Treat Acute Ischemic Stroke Patients During Mechanical Thrombectomy
Neuravi Limited17 个研究点 分布在 5 个国家目标入组 74 人开始时间: 2026年2月2日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 17
- 主要终点
- Third Pass Reperfusion Assessed by Independent Imaging Core Lab
研究概览
简要总结
The purpose of this study is to assess the safety and the effectiveness of the Adaptive Tip Catheter (ATC) used as a first line direct aspiration thrombectomy technique for patients suffering of an acute ischemic stroke.
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
- •Age greater than or equal to (>=) 18 years, less than or equal to (<=) 90 years, at the time of consent
- •Signs and symptoms consistent with the diagnosis of acute ischemic stroke in the anterior circulation that can be treated with endovascular thrombectomy approaches
- •Endovascular treatment can be initiated (defined as access puncture) within 24 hours from time last known well
- •Baseline National Institutes of Health Stroke Scale (NIHSS) score >= 6
- •Baseline Alberta Stroke Program Early CT Score (ASPECTS) >= 3
- •A signed and dated Informed Consent Form (ICF) or Investigator Statement for emergency procedure (as allowed according to country regulations and approved by EC) has been obtained
排除标准
- •Known pregnancy, as evidenced by positive pregnancy test for women of childbearing potential or breast feeding
- •Life expectancy less than (<) 90 days prior to stroke onset
- •Known hemorrhagic diathesis disorder, coagulation factor deficiency or oral anticoagulant therapy with known International Normalized Ratio (INR) greater than (>) 3.0
- •Clinical symptoms and/or CT/MRI evidence suggestive of bilateral stroke or stroke in multiple vascular territories, defined as occlusions in more than one vessel not downstream from each other (for example, bilateral anterior circulation, anterior/posterior circulation)
- •Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic
- •Computed Tomography/ Magnetic Resonance Imaging (CT/MRI) evidence of recent/fresh hemorrhage
- •Baseline CT or MRI showing mass effect
- •Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible
- •Cerebral catheter angiographic evidence of pre-existing arterial disease, that potentially impacts treatment and/or outcome (for example, vasculitis)
- •Any occlusion or stenosis that limits device access to the target area (for example, carotid dissection, tandem occlusions) or requiring acute stenting to achieve access
- •Cerebral catheter angiographic evidence of multiple cerebrovascular occlusions, defined as occlusions in more than one vessel not downstream from each other (for example, bilateral anterior circulation, anterior/posterior circulation)
- •Excessive vascular access tortuosity that will likely prevent endovascular access with the adaptive tip catheter (ATC)
- •Baseline expanded thrombolysis in cerebral infarction (eTICI) > 1
研究组 & 干预措施
Adaptive Tip Catheter (ATC)
Experimental
The ATC will be used alone (direct aspiration) as the first attempted device/technique for mechanical thrombectomy in the anterior circulation in patients during the first three passes or until final reperfusion, if less than three passes are needed. Patients will be followed over 90 days post procedure.
干预措施: Adaptive Tip Catheter (Procedure)
结局指标
主要结局
Third Pass Reperfusion Assessed by Independent Imaging Core Lab
时间窗: Intraoperative
Successful achievement of the third pass reperfusion is defined as achieving an Expanded Thrombolysis in Cerebral Infarction (eTICI) score of 2b50 or greater using no more than three passes with the study device in the target vessel, and without any rescue therapy.
次要结局
- All-Cause Mortality(At 90 days post-procedure)
- First Pass Reperfusion(Intraoperative)
- Final Procedural Reperfusion(Intraoperative)
- Modified Rankin Scale (mRS) Score of 0-2 at 90 days Post-Procedure(At 90 days post-procedure)
- Vessel Damage(At 90 days post-procedure)
- Symptomatic Intracranial Hemorrhage (sICH) at 24 hours(At 24 hours after intervention)
研究者
研究点 (17)
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