Contact Aspiration Versus Stent Retriever for Recanalisation of Acute Stroke Patients With Basilar Artery Occlusion: The Posterior Circulation ASTER Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Hopital Foch
- 入组人数
- 480
- 试验地点
- 12
- 主要终点
- Rate of first pass effect (FPE) defined by complete reperfusion after first device pass
研究概览
简要总结
Acute ischemic stroke (AIS) patients with basilar artery occlusion (BAO) present a devastating, life-threatening prognosis.
Urgent recanalization with endovascular mechanical thrombectomy is routinely performed in patients with BAO although the level of evidence is lower than that in anterior circulation occlusions (randomization in this population versus medical treatment alone having been impossible in recent studies). Recently, a large retrospective study supports the interest of thrombectomy in this population .
Speed and grade of the recanalisation have a major impact on clinical outcome. Favorable outcome at 90 days is strongly associated with the successful recanalization status at the end of the endovascular procedure (OR=4.57, 95%CI=1.24-16.87, P=0.023).
First pass effect has been shown to be a strong marker of efficacy of endovascular procedure with significant correlation with clinical outcome.
Thrombectomy with Stent retrievers dramatically changed the prognosis of anterior circulation large vessel occlusion strokes and currently used in BAO patients (posterior circulation). Contact aspiration (CA) is currently used in anterior large vessel occlusions (COMPASS trial, Lancet 2019), with similar rates of recanalization and favorable outcomes (Boulanger M, 2019), as well as in BAO patients .
However, the benefit of CA compared to SR for the treatment of BAO remains under debate with the superiority of first line CA compared to SR or no difference. Available data are based on retrospective studies with no data from RCT.
In this context, a randomized controlled trial is needed to assess the benefit of CA versus SR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •AIS with BAO on non-invasive imaging (CT or MRI)
- •Eligible for thrombectomy : groin puncture undergone within 24 hours of first symptoms or of last time the patient was seen normal
- •Being covered by a national health insurance
- •Informed consent obtained from the patients/his proxy or following an emergency procedure
排除标准
- •Known or suspected pre-existing (chronic) large vessel stenosis / occlusion in the symptomatic territory (basilar artery)
- •Severe contrast medium allergy or absolute contraindication to use of iodinated products
- •Clinical history, past imaging or clinical judgment suggesting intracranial stenosis of the basilar artery
- •Pregnancy (urine or serum beta HCG test for women of child-bearing potential)
- •Person deprived of liberty
- •Patient benefiting from a legal protection (guardianship or curatorship)
结局指标
主要结局
Rate of first pass effect (FPE) defined by complete reperfusion after first device pass
时间窗: 24 hours
The definition of FPE: single pass/use of the device, (2) complete revascularization of the large vessel occlusion and its downstream territory (mTICI 3), and (3) no use of rescue therapy
次要结局
- Rate of complete reperfusion after first-line thrombectomy strategy and at the end of endovascular procedure(24 hours)
- Rate of successful reperfusion (mTICI 2b/2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure(24 hours)
- Rate of near to complete reperfusion (mTICI 2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure(24 hours)
- Rate of Arterial Occlusive Lesion (AOL) recanalization score III after first-line thrombectomy strategy and at the end of endovascular procedure(24 hours)
- Groin puncture time to successful reperfusion time (evaluated in minutes)(360 minutes)
- Modified Rankin Score (mRS) at 3 and 12 months(12 months)
- Rate of good functional outcome at 90-day and at one year defined by a mRS 0-3 or equal to pre-stroke mRS (Modified Rankin Score)(12 months)
- Quality of life at 90 days and 12 months assessed by EuroQol 5D-5L scale(12 months)
- All cause of mortality at 90-day and 12 months(12 months)
- 24-hours change in NIHSS (National Institutes of Health Stroke Scale) from baseline defined as the difference between NIHSS score at 24 hours and NIHSS score at admission.(24 hours)
- Subgroups analysis : Age (≤70 vs. >70 years)(24 hours)
- Subgroups analysis :Baseline NIHSS≥10 vs NIHSS<10 (18)(24 hours)
- Subgroups analysis : Volume of infarct area assessed by pc-ASPECTS (≤7 vs. >7)(24 hours)
- Subgroups analysis : Time from admission of patient in hospital to randomization (≤ 300 vs. > 300 minutes)(360 minutes)
- Subgroups analysis: Baseline site of thrombi on vascular imaging (Top of the basilar artery vs other adjudicated by the core lab)(24 hours)
- Subgroups analysis: Prior use of IV alteplase (yes vs. no)(24 hours)
- Subgroups analysis : Collateral status (good versus poor, as adjudicated by the core lab on initial angiogram) with a 0-3 scale(24 hours)
- Incidence of any intracerebral hemorrhage (ICH), parenchymal hematoma (PH), symptomatic ICH on brain imaging (Magnetic resonance imaging MRI or CT (computed tomography) scan) at 24±12h after thrombectomy (according to ECASS3 classification)(24 hours)
- Incidence of procedure-related complications defined as arterial perforation, arterial dissection, embolization in a new territory (ENT) and subarachnoid haemorrhage(hours)
- Cost-effectiveness analysis at 12 months(12 months)