A Randomized Study to Compare the Efficacy of Primary Thrombectomy With Double Stent (DS-EVT) Versus Primary Thrombectomy With One Stent (SS-EVT) as an Initial Attempt at Thrombectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Complete recanalization on first pass
研究概览
简要总结
The use of a double stent retriever (Dual-SR) has been proposed as a safe and effective technique. The invesigators hypothesized that the use of Dual-SR primary could lead to higher first-pass effect rates and better outcomes compared to Single-SR primary.
Our goal is to develop a research project to provide additional information on the potential benefits of the simultaneous double stent approach primarily in stroke patients receiving TVS.
A randomized study to compare the efficacy of double primary SR versus single primary SR
详细描述
Prospective, multicenter, randomized, controlled, open and blinded trial of patients with acute stroke with acute large vessel occlusion (LGO) identified by ASD, in which two strategies will be compared: primary double stent (DS-EVT) versus simple stent (SS-EVT) as an initial attempt at thrombectomy.
Assignment will be stratified according to the initial location of the occlusion: terminal ICA, distal M1, and basilar artery.
The primary objective will be to evaluate the efficacy of the primary strategy DS-EVT defined as first-pass angiographic complete recanalization (TICI 2c-3) compared to SS-EVT.
The primary safety endpoint will assess the safety of the primary DS-EVT strategy compared to SS-EVT, defined as the occurrence of symptomatic intracerebral hemorrhage (sICH), along with any other serious procedure-related adverse events. (excluding those already accounted for in sICH) within 24 hours (-8/+12) after the procedure.
A designated Data Safety Monitoring Board (DSMB) will review the primary safety endpoint after every 25 new patients enrolled in the study and determine continuation of the study based on the occurrence of adverse events in each study arm to assess early completion of the study. A first interim efficacy analysis will be performed after enrolling 106 patients and enrollment will be stopped if a significant difference in first-pass recanalization between both groups is demonstrated according to pre-specified stopping rules.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤85 years. Informed consent obtained from the patient or an acceptable surrogate for the patient (ie, next of kin or legal representative).
- •A new disabling focal neurological deficit compatible with acute cerebral ischemia.
- •Baseline NIHSS obtained before the procedure, ≥ 6 points. Preictal mRS score of 0 or
- •Treatable as soon as possible and at least within 24 hours of symptom onset, defined as the time the patient was last seen well (at baseline).
- •Patients for whom IV t-PA is indicated and who are available for treatment are treated with IV t-PA. For those patients for whom IV t-PA is indicated and available for treatment, IV t-PA should be administered as recommended in the AHA/ASA Guidelines for the Early Management of Patients with Acute Ischemic Stroke ( AIS).
- •Neuroimaging
- •Occlusion (flow TICI 0 or TICI 1), of the terminal internal carotid artery, segments or distal M1 of the basilar or middle cerebral artery, suitable for mechanical embolectomy, confirmed by conventional angiography.
- •The patient is indicated for neurothrombectomy treatment by the Interventionist.
- •Participating NRIs will have to complete a teaching module on the DS-EVT
排除标准
- •Functional disability prior to stroke on the modified Rankin scale (mRS >2). Initial treatment with a different thrombectomy device. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
- •Known bleeding diathesis, coagulation factor deficiency, or known oral anticoagulant therapy with INR > 3.
- •Baseline platelet count < 50,
- •Serious, advanced or terminal illness with an expected life expectancy of less than six months.
- •Subjects with identifiable intracranial tumors. Brain vasculitis. Evidence of active systemic infection. Known current use of cocaine at the time of treatment. Woman of childbearing age who is known to be pregnant, and/or breastfeeding, or who has a positive pregnancy test at the time of admission.
- •Patient participating in a study involving an investigational drug or device that may affect this study.
- •Patients who are unlikely to be available for a 90-day follow-up (eg, homeless, visitor from abroad).
- •Neurological imaging
- •Hypodensity on CT or diffusion-restricted resulting in an ASPECTS score of < 6 on CT or < 5 on DMR (diffusion-weighted MRI).
- •Evidence of hemorrhage on CT or MRI (the presence of microbleeds is allowed). Angiographic evidence of carotid artery dissection, high-grade stenosis impeding access to the clot, or vasculitis.
- •Significant mass effect with midline shift. Patients with known or suspected underlying intracranial atherosclerotic lesions responsible for the target occlusion.
- •Patients with occlusions in multiple vascular territories (for example, bilateral anterior circulation or anterior/posterior circulation).
- •Evidence of intracranial tumor (except small meningiomas). Suspected aortic dissection, suspected septic embolus, or suspected bacterial endocarditis.
研究组 & 干预措施
double stent retriever
干预措施: Thrombectomy (Device)
single stent retriever
干预措施: Thrombectomy (Device)
结局指标
主要结局
Complete recanalization on first pass
时间窗: 4 months
Comparison of the complete recanalization rate in the first pass in the double stent group compared to the simple stent group, defined as TiCI greater than 2c on the Thrombolysis in Cerebral Infarction scale (eTICI scale)
次要结局
- Intracerebral hemorrhage(4 months)
- Embolization in new territories(4 months)
- Mortality(4 months)
- Neurological impairment(4 months)
- Infarct in new territory(4 months)