Acandis Credo Intracranial Stent for Unsuccessful Recanalization After Thrombectomy (ACUTE)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Acandis GmbH
- 入组人数
- 27
- 试验地点
- 15
- 主要终点
- Co-Primary Clinical Efficacy Endpoint
研究概览
简要总结
Study objective is to evaluate the efficacy and safety of acute permanent stenting of symptomatic intracranial stenosis following unsuccessful recanalization by thrombectomy in acute ischemic stroke with large vessel occlusion using the self-expandable Credo® stent together with the NeuroSpeed® PTA balloon catheter.
详细描述
Prospective, interventional treatment, single-arm, open-label, multi-center trial.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke from large vessel occlusion (LVO)
- •Failed recanalization after treatment with thrombectomy, i.e. persistent occlusion of intracranial internal carotid artery (ICA), proximal segment (M1, M2) of the middle cerebral artery (MCA) (TICI 0-1)
- •Small to moderate infarct core prior to initiation of thrombectomy (CT ASPECTS 6-10, DWI lesion < 70 ml)
- •Suspected underlying stenosis of the occluded artery amenable to stenting by judgement of the treating neurointerventionalist
- •Age 18- 80 years
- •Informed consent (see below)
- •Decision to perform angioplasty and stenting < 12 hours of symptom onset
- •Previous passage of occlusion with microcatheter obtained
排除标准
- •Large infarct core prior to initiation of thrombectomy (CT ASPECTS 0-5, DWI lesion > 70 ml)
- •Vessel occlusion or stenosis of different known or suspected cause than atherosclerosis (e.g. vasculitis)
- •Pre-stroke disability (MRS > 2)
- •Any sign of intracranial haemorrhage on brain imaging prior to thrombectomy
- •Any sign of intracranial vessel perforation during thrombectomy
- •Contraindication against treatment with double anti-platelet treatment
- •Current effective use of oral anticoagulants (e.g. INR > 1.7 for Vitamin K antagonists)
- •More than 3 attempts for recanalization of target lesion prior to the use of the study device.
- •Stenosis longer than the working length of the NeuroSpeed PTA balloon catheter.
- •Diameter of the healthy vessel proximal and distal to the stenosis prevents save treatment with the NeuroSpeed PTA balloon catheter or is outside the indicated range of the Credo stent.
- •Diameter of the target area is outside the indicated range of the Credo stent after predilation.
- •Contraindication against anti-platelet or anticoagulation therapy
- •Heavily calcified lesions that may prevent access or safe stent placement.
- •Pregnant and breastfeeding women
结局指标
主要结局
Co-Primary Clinical Efficacy Endpoint
时间窗: 90 +/- 10 days after stroke
Good clinical outcome 90 (±10) days after stroke defined as a score of 0-2 on the modified Ranking Score (MRS 0-2).
Primary Safety Endpoints
时间窗: Within 18-36 hours after treatment
* Symptomatic intracranial hemorrhage (SICH) as defined in SITS-MOST (within 18-36 hours of treatment) * Device-related procedural complications: Dissection, perforation or rupture of the target vessel, embolism, stent thrombosis or occlusion, stent migration.
Co-Primary Technical Efficacy Endpoint
时间窗: Assessed after interventional procedure
Technical success defined as successful recanalization of the occluded vessel (TICI 2b-3) at the end of the procedure (successful PTA + permanent stenting).
次要结局
- Secondary Safety Endpoints(90 +/- 10 days after stroke)
- Secondary Efficacy Endpoints(90 +/- 10 days after stroke)