Tigertriever Distal Vessels Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Percentage of participants with Symptomatic Intracranial Hemorrhage (SICH) or new infarct within 24 (±12) hours post-procedure.
研究概览
简要总结
A registry study to collect data on the Tigertriever device at restoring blood flow by removing clots in M2 or distal vessels in patients experiencing acute ischemic stroke, during commercial use.
详细描述
Tigertriever is a CE marked mechanical revascularization device indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 who present with acute ischemic stroke, who can be treated within 6 hours of symptoms onset, who are either refractory to or ineligible for IV t-PA treatment and intend to be treated with thrombectomy.
- •Patients ≥18
- •NIHSS Score of ≥2
- •Angiographically confirmed occlusion in a M2 or distal (medium to small) branch that is accessible to the Tigertriever device (17 or 13) as determined by the vessel diameter (≥1mm).
- •Anticipated life expectancy of at least 6 months from presentation
- •Signed informed consent form by the patient or a legally acceptable representative.
排除标准
- •Extended infarct - ischemic changes >1/3 MCA territory / 100 ml tissue or ASPECT score <5
- •Pre- stroke mRS ≥ 2
- •Unknown time of stroke symptom onset
- •Vessel diameter < 1mm
- •Angiographically evident extreme vessel tortuosity that may preclude the device from reaching the target area.
- •Occlusion/stenosis proximal to thrombus that precludes safe retrieval
- •Medical co-morbidities including but not limited to:
- •Uncontrolled coagulopathy such as International Normalized Ratio (INR) of > 3.0 or platelets count < 40 x109/L or APTT >50 sec
- •Serious concurrent medical illness: myocardial infarction, seizures, sepsis, uncontrolled diabetes, uncontrolled hypertension, brain tumor, renal impairment (eGFR <60).
- •Baseline glucose < 2.7 or > 22.2 mmol/L
- •Imaging features of:
- •raised intracranial pressure or significant mass effect (for example, midline shift, severe sulcal effacement, transcompartmental herniation)
- •intracranial hemorrhage
- •vascular malformation or aneurysm
- •significant vascular abnormality such as carotid dissection, complete carotid occlusion or large/medium vessel vasculitis
- •Allergy/sensitivity to nickel-titanium or contrast media
- •Females who are pregnant or lactating
- •Unable to obtain informed consent from the patient or a suitable legal representative
- •Any other contraindication to thrombectomy
结局指标
主要结局
Percentage of participants with Symptomatic Intracranial Hemorrhage (SICH) or new infarct within 24 (±12) hours post-procedure.
时间窗: 24 hours post procedure
Safety Endpoints. SICH shall be defined as Parenchymal Hematoma type 2 coupled with ≥4-point NIHSS deterioration at 24 hours.
Percentage of participants with a new occlusion.
时间窗: Day 0 (end of procedure)
Safety Endpoints.
Percentage of participants with a TICI Score ≥IIb post procedure after first pass.
时间窗: Day 0 (end of procedure)
Effectiveness Endpoints
Percentage of participants with a TICI Score ≥IIb post procedure.
时间窗: Day 0 (end of procedure)
Effectiveness Endpoints
次要结局
未报告次要终点