Medical Management With Endovascular Thrombectomy Versus Medical Management Alone in Patients Presenting Beyond 24 Hours of Last Known Well - SELECT LATE Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 408
- 试验地点
- 6
- 主要终点
- The distribution of the modified Rankin Scale score
研究概览
简要总结
SELECT LATE trial aims to evaluate if addition of endovascular thrombectomy to medical management in patients presenting with acute ischemic stroke and a proximal large vessel occlusion in the anterior circulation between 24 and 72 hours of stroke onset results in achieving better functional outcomes (measured using modified Rankin Scale Scores) at 90-day follow-up (± 15 days).
详细描述
SELECT LATE is a prospective, phase III, randomized, international, multicenter, assessor-blinded controlled trial evaluating if addition of endovascular thrombectomy to medical management in patients presenting with acute ischemic stroke and a proximal large vessel occlusion in the anterior circulation between 24 and 72 hours of stroke onset results in achieving better functional outcomes (measured using modified Rankin Scale Scores) at 90-day follow-up (± 15 days).
Patients with the final diagnosis of an acute ischemic stroke due to a large vessel occlusion in the internal carotid artery (ICA) or M1 segment of the middle cerebral artery (MCA), who present between 24-72 hours of when they were last known to be well and meet neuroimaging eligibility criteria [Non-contrast CT ASPECTS 3-10 and Ischemic core volume ≤150ml] will be randomized in a 1:1 ratio to thrombectomy plus medical management vs medical management alone. Patient assessments will be made at baseline, 24 hours post-randomization, discharge, 90 days and 1 year.
The primary endpoint is the Modified Rankin Scale (mRS) score at 90 (+/- 15) days. The primary outcome is a shift on 90-day mRS scores, with scores of 5 (severe disability requiring constant care) and 6 (death) merged to avoid considering a shift from 6 to 5 as an improvement. Secondary outcomes include functional independence (mRS score of 0-2), Utility weighted mRS, and Quality of Life measures. Safety outcomes include mortality, severe disability or death (mRS 5-6), incidence of symptomatic intracranial hemorrhage (sICH per SITS-MOST); and Imaging outcomes include infarct volume on MRI diffusion-weighted imaging (DWI) sequence (or CT if MRI is not feasible) 24-72 hours after randomization.
A maximum of 408 patients will be randomized across the study sites. Online randomization with Common Scale-Minimum Sufficient Balance algorithm will be used to balance the distribution of important variables. Interim analyses will be conducted at 136 and 272 patients, at which time the study may stop for efficacy or futility.
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
- •General Inclusion Criteria:
- •Adults (18-85* years) with the final diagnosis of an acute ischemic stroke$
- •NIHSS ≥ 6
- •Time from last-known-well to randomization >24 - 72 hours
- •Pre-stroke modified Rankin Scale score of 0-1
- •Eligible for thrombectomy and medical management
- •Signed Informed Consent obtained
- •Subject willing to comply with the protocol follow-up requirements
- •Anticipated life expectancy of at least 3 months *Inclusive of both 18 and 85 years of age (i.e. up to 86th birthdate). $Subacute presentation - In-hospital stroke admissions with fluctuating clinical symptoms for patients who presented to EVT centers within 24 hours of when they were last known well will not be eligible for the trial.
排除标准
- •Current participation in another investigational interventional drug or device study.
- •Baseline Platelet count <100,000/μl
- •Imaging Inclusion Criteria
- •Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions), as determined by MR Angiography (MRA) or CT Angiography (CTA)
- •CT ASPECTS 3-10
- •CT Perfusion ischemic core (rCBF <30%)# volume ≤150 ml OR MR Diffusion ischemic core (ADC <620x10-6 mm2/s)# volume ≤150ml #If the perfusion software at enrollment center uses another threshold/measure to define ischemic core, please use that measure to assess ischemic core criteria.
- •Imaging Exclusion Criteria
- •Evidence of intracranial tumor (except small meningioma <3cm without signs of edema or inflammation), acute intracranial hemorrhage, or arteriovenous malformation
- •Significant mass effect, defined as midline shift (>3mm) using foramen of monroe (anterior margin of third ventricle) as the marker for midline instead of septum pellucidum AND/OR Effacement of sulci in contralateral hemisphere
- •Evidence of internal carotid artery dissection that is flow limiting or aortic dissection
- •Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device
- •Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).
- •Any signs of established infarct, demarcating hypodensity and area of cerebral edema on non-contrast CT
- •CT ASPECTS 0-2
- •CT Perfusion ischemic core (rCBF <30%)# volume >150 ml OR MR Diffusion ischemic core (ADC <620x10-6 mm2/s)# volume >150ml #If the perfusion software at enrollment center uses another threshold/measure to define ischemic core, please use that measure to assess ischemic core criteria.
研究组 & 干预措施
Medical Management with Endovascular Thrombectomy
Medical management with endovascular thrombectomy (EVT) - EVT will be provided in addition to medical management and is a procedure to remove a thrombus in one of the brain arteries that is obstructing the blood flow. Removing this occlusion results in restoration of blood flow to ischemic brain tissue and salvage of the parts that are still viable, which is expected to improve functional outcomes. Endovascular thrombectomy procedure will be performed using stent retrievers, aspiration devices or combination approach at the discretion of the treating physician, using devices approved by the local regulatory authority. For patients treated in the United States of America, only US Food and Drug Administration-approved neurothrombectomy devices can be used.
干预措施: Endovascular Thrombectomy (Device)
Medical Management with Endovascular Thrombectomy
Medical management with endovascular thrombectomy (EVT) - EVT will be provided in addition to medical management and is a procedure to remove a thrombus in one of the brain arteries that is obstructing the blood flow. Removing this occlusion results in restoration of blood flow to ischemic brain tissue and salvage of the parts that are still viable, which is expected to improve functional outcomes. Endovascular thrombectomy procedure will be performed using stent retrievers, aspiration devices or combination approach at the discretion of the treating physician, using devices approved by the local regulatory authority. For patients treated in the United States of America, only US Food and Drug Administration-approved neurothrombectomy devices can be used.
干预措施: Medical Management (Other)
Medical Management without Endovascular Thrombectomy
Medical management without endovascular thrombectomy comprises various measures to prevent further deterioration, enhance patients' outcomes and prevent occurrence of a secondary stroke in short and long term. This includes 1) evidence-based practices for blood pressure management 2) Neurocritical care monitoring with appropriate osmotic therapy and neurosurgical interventions such as hemicraniectomy for management of cerebral edema that occurs due to infracted brain tissue based on local institutional protocol, 3) stroke etiology identification by requisite neurology , cardiology, immunology evaluations and 4) short and long-term strategies for secondary stroke prevention, including anticoagulation, antiplatelet therapy, medical optimization and modification of stroke risk factors such as hypertension, hyperlipidemia, diabetes and other potential comorbidities.
干预措施: Medical Management (Other)
结局指标
主要结局
The distribution of the modified Rankin Scale score
时间窗: 90 days ± 15 days
The modified Rankin Scale (a 7-point scoring system, 0 indicates no residual stroke symptoms and 6 represents death) is assessed through patient/caregiver interview by trained and certified raters. The modified Rankin Scale score is the standard FDA-recognized measure of stroke outcome, used in clinical trials testing acute stroke therapies.
次要结局
- Utility-weighted modified Rankin Scale scores(90 days ± 15 days)
- Domain-specific scores for NeuroQoL(90 days ± 15 days)
- Functional independence (mRS 0-2)(90 days ± 15 days)
- Domain-specific scores for NeuroQoL(1 year ± 30 days)
- Functional independence (mRS 0-2)(1 year ± 30 days)
- The distribution of the modified Rankin Scale score(1 year ± 30 days)
- Utility-weighted modified Rankin Scale scores(1 year ± 30 days)
研究者
Amrou Sarraj
Professor of Neurology at the CWRU School of Medicine
University Hospitals Cleveland Medical Center