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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed Description

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. While the Prolyse in Acute Cerebral Thromboembolism-II trial (PROACT-II) showed that IAT fibrinolysis, using a drug that is no longer available, improves clinical outcome, the Interventional Management of Stroke-III (IMSIII), SYNTHESIS and The Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy (MR RESCUE) trials failed to show that IAT confers an increased benefit compared with IV t-PA or that IAT improves outcome as an adjunctive approach with IV t-PA.
In December 2014, The Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands (MR CLEAN) became the first positive study since PROACT II showing benefit from IAT in AIS patients with LAO. Furthermore, with the recently published results of ESCAPE, EXTEND-IA, SWIFT PRIME and REVASCAT showing overwhelming efficacy of endovascular therapy, there is no longer equipoise to randomize patients to medical therapy in comparison to IAT, and thus future trials should assess strategies to enhance clinical outcomes and optimization of patient selection . 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.

Conditions

Interventions

  • Mechanical Thrombectomy (Merci Retriever)Device
    Other Names: Penumbra system; TREVO; Solitaire
    Intervention Desc: Mechanical thrombectomy includes the use of stent retrievers (i.e. Trevo®, Solitaire®) as recommended by AHA guidelines (July 2015). A stent retriever is delivered directly to a thromboembolus that is occluding a cerebral artery to restore blood flow.
    ARM 1: Kind: Experimental
    Label: Stroke with Mechanical Thrombectomy
    Description: Eligible patients will be adults ≥18 with the final diagnosis of an acute ischemic infarction and large artery occlusion in anterior circulation strokes who undergo endovascular therapy

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

Eligible patients will be adults (≥18 with the final diagnosis of an acute ischemic infarction and large artery occlusion in anterior circulation strokes). Given the observational design of the study there will be no stringent exclusion based on stroke severity or IV tPA treatment

Outcomes

Type Measure Time Frame Safety Issue
Primary Day 90 modified rankin scale 90 Days No
Secondary Safety (incidence of: hemorrhage; mortality; hematoma, infection, vascular injury) 90 Days Yes
Secondary Rates of recanalization post-procedure (expected average of 6-12hrs after hospital admittance) No

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