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临床试验/NCT02446587
NCT02446587已完成不适用

Optimizing Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT)

The University of Texas Health Science Center, Houston9 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
9
主要终点
Day 90 modified Rankin scale

研究概览

简要总结

SELECT is a multicenter, observational prospective study implementing a protocol to acquire imaging and clinical variables known to affect clinical outcomes after endovascular therapy in an effort to evaluate and compare the different selection methods and criteria currently used in practice for acute ischemic stroke patients in the anterior circulation with large vessel occlusion. The study aim is to evaluate prospectively different selection methodologies for endovascular therapy, to compare them against each other to identify which method provides the highest predictive ability in the selection of patients for IAT and to devise a formula that predicts patients' outcomes.

This study will enroll patients based on the recent AHA guidelines (July 2015) regarding treatment of patients with acute ischemic strokes and large artery occlusions in the anterior circulation.

Our goal is to collect complete imaging, clinical, and 90 day follow up data on 250 endovascular therapy patients as well as up to 250 concurrent medical management patients as a comparison group.

详细描述

Improving reperfusion status is the most effective therapeutic approach for patients with acute ischemic strokes (AIS) due to large artery occlusion (LAO). Intra-Arterial Therapy (IAT) by means of mechanical thrombectomy and/or chemical fibrinolysis has been adopted worldwide to recanalize LAO strokes. IAT is now the standard of care for AIS patients with LAO based on the results of five randomized clinical trials. However, these trials implemented different imaging methodologies for patient treatment with IAT. Specially, these trials were designed to use one or another selection methodology without knowing which may be superior and more effective in selecting patients that may or may not benefit from the intervention.

Decisions to pursue IAT are clinician-dependent and rest upon a number of different factors that may differ from one center to another and even in the same center from one treating physician to another. The Alberta Stroke Program Early CT Score (ASPECTS) has demonstrated utility in selecting candidates for recanalization strategies using a simple noncontrast head CT (NCCT). Numerous other studies suggest the utility of magnetic resonance imaging (MRI), CT angiography (CTA) and CT perfusion in identifying patients who have poor outcome after thrombolysis.

However, the current widely practiced selection methodologies have never been tested against one another in the context of a prospective trial to evaluate their sensitivity, specificity and superiority, which is in our opinion (and shared by many treating vascular neurologists), a major question that is being asked on daily basis by the treating physicians. Furthermore, prognostication and informing stroke patients' families of their chances of having good outcomes after Intra-Arterial Therapy is crucial and depends to a large extent on the clinical and imaging variables utilized prior to IAT as well as on the success of the intervention itself.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible patients will be:
  • Adults (≥18years) with the final diagnosis of an acute ischemic stroke
  • CT-Angiogram proven, large artery occlusion (LAO) in the internal carotid artery (ICA), middle cerebral artery (MCA -M1 or M2 site) locations
  • NIH Stroke Scale ≥6 (NIHSS) OR proven LAO on imaging (must be from designated LAO listed on inclusion #2)
  • LSN (last seen normal) to groin puncture (≤ 8 hours) in thrombectomy arm; LSN to presentation to endovascular capable center (≤ 8 hours) in medical arm
  • Baseline modified Rankin Scale score of 0-1
  • Signed Informed Consent obtained
  • Subject willing to comply with the protocol follow-up requirements
  • Anticipated life expectancy of at least 3 months
  • IV-tPA eligible patients must meet AHA guidelines

排除标准

  • Patients are excluded if:
  • Inability to undergo CT-Angiography and/or CT-Perfusion imaging (e.g., renal insufficiency, iodine/contrast allergy)
  • Co-morbid psychiatric or medical illnesses that would confound the neurological assessments
  • Subject is participating in another mechanical neuro-thrombectomy device trial (intervention) or any other trial where the study procedure or treatment might confound the study endpoint.

结局指标

主要结局

Day 90 modified Rankin scale

时间窗: 90 Days

Favorable primary clinical outcome will be patients functional outcomes at 90 (+/- 15) days measured by modified Rankin scale (mRS) score 0-2

次要结局

  • Safety (incidence of: hemorrhage; mortality; hematoma, infection, vascular injury)(90 Days)
  • Rates of recanalization(post-procedure (expected average of 6-12hrs after hospital admittance))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amrou Sarraj

Associate Professor

The University of Texas Health Science Center, Houston

研究点 (9)

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