Boosting REcanalization of Thrombectomy for Ischemic Stroke by Intra-arterial TNK (BRETIS-TNK): a Prospective, Random, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of sufficient recanalization
研究概览
简要总结
Thrombolysis and endovascular thrombectomy are the most efficient treatments for acute ischemic stroke patients in time window. However, sufficient recanalization (mTICI2b-3) can 't be acquired in all patients under thrombectomy. The EXTEND-IA TNK study indicated that tenecteplase before thrombectomy was associated with a higher incidence of reperfusion and better functional outcome than alteplase among patients with ischemic stroke treated within 4.5 hours after symptom onset. This study intends to explore whether a combination of thrombectomy and intra-arterial TNK administration can increase recanalization rate after the first attempt of thrombectomy device pass for 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy;
- •The subtype of ischemic stroke is large-artery atherosclerosis according to TOAST classification;
- •The availability of informed consent.
排除标准
- •Other sub-types of ischemic stroke such as cardioembolism.
- •Hemorrhagic stroke such as cerebral hemorrhage, subarachnoid hemorrhage.
- •Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (<100000/mm3).
- •Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis.
- •Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg).
- •Patients allergic to any ingredient of drugs in our study.
- •Unsuitable for this clinical studies assessed by researcher.
研究组 & 干预措施
intra-arterial tenecteplase administration
Intra-arterial administration of 4mg tenecteplase is given after microcatheter navigation through the clot. Intra-arterial administration of tenecteplase (0.4 mg/min) continuously is given after the first attempt of thrombectomy device pass for 30 minutes, and then followed by DSA
干预措施: intra-arterial tenecteplase administration (Drug)
结局指标
主要结局
Proportion of sufficient recanalization
时间窗: Immediately after TNK treatment
sufficient recanalization is defined as TICI 2b-3
次要结局
- Proportion of favorable outcome(90 days)
- proportion of early neurological improvement(48 hours)
研究者
Hui-Sheng Chen
Professor
General Hospital of Shenyang Military Region