Combined Use of Contact Aspiration and the Stent Retriever Technique Versus Stent Retriever Alone for Recanalisation in Acute Cerebral Infarction: the Randomized ASTER2 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 408
- 试验地点
- 13
- 主要终点
- Perfect reperfusion rate
研究概览
简要总结
Mechanical thrombectomy (MT) with a stent retriever (SR) device is now the standard intervention in ischemic stroke with large vessel occlusion. Favorable outcome is strongly associated with the successful reperfusion status. New device of MT such as contact aspiration seems promising to increase reperfusion status and clinical outcome.
The main hypothesis is to show the superiority of combining the use of contact aspiration with a stent retriever compared to a stent retriever alone in treatment of acute stroke due to proximal arterial occlusion.
The primary endpoint is the rate of perfect reperfusion score at the end of the endovascular procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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 and older (i.e., candidates must have had their 18th birthday)
- •Groin puncture carried out within 8 hours of first symptoms
- •Neuroimaging demonstrates large vessel proximal occlusion (distal ICA through MCA bifurcation, M1 or M2)
- •Consenting requirements met according to French laws.
- •With or without intravenous thrombolysis
排除标准
- •Absence of large vessel occlusion on non-invasive imaging
- •Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory
- •Suspected pregnancy; if, a woman is of childbearing potential, a urine or serum beta human chorionic gonadotropin (betaHCG) test is positive.
- •Severe contrast medium allergy or absolute contraindication to iodinated agents.
- •Patient has severe or fatal comorbidities that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
- •Acute ischemic stroke involving posterior circulation (vertebrobasilar occlusion)
- •Angiographic evidence of carotid dissection or tandem cervical occlusion or stenosis requiring treatment.
- •Patients benefiting from a legal protection
- •Non-membership of a national insurance scheme
- •Opposition of the patient or (in case of inclusion as a matter of urgency) of the trustworthy person
结局指标
主要结局
Perfect reperfusion rate
时间窗: 24 hours
Perfect reperfusion rate at the end of angiography defined as a Thrombolysis In Cerebral Infarction (TICI) 2c/3 score (TICI score = Thrombolysis In Cerebral Infarction)
次要结局
- Average cost per patient(90 days)
- Rate of periprocedural complications(90 days)
- Modified Rankin scale (mRs)(90 days)
- Rate of symptomatic and asymptomatic intracerebral hemorrhage(24 hours)
- Rate of all-cause mortality(90 days)
- Rate of favorable functional independence(90 days)
- Rate of excellent functional outcome(90 days)
- NIHSS score(24 hours)
- Rate of successful reperfusion(24 hours)
- Rate of perfect (mTICI 2c/3), successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) after the frontline strategy(24 hours)
- Rate of parenchymal hematoma(90 days)
- Time from groin puncture to achieve TICI 2c or better revascularization(24 hours)
- Time between groin puncture to clot contact and clot contact to maximum reperfusion(24 hours)