Optimizing Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT)
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|ClinicalTrials.gov Identifier: NCT02446587|
Recruitment Status : Completed
First Posted : May 18, 2015
Last Update Posted : April 16, 2019
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.
|Condition or disease||Intervention/treatment|
|Stroke Ischemic Stroke||Device: Mechanical Thrombectomy|
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.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Optimizing Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT)|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||May 2018|
|Actual Study Completion Date :||May 2018|
Stroke with Mechanical Thrombectomy
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 with mechanical thrombectomy utilizing stent retrievers
Device: Mechanical Thrombectomy
Mechanical thrombectomy includes the use of stent retrievers (i.e. Trevo®, Solitaire®, or other stent retriever devices) 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.
Stroke without Mechanical Thrombectomy
Patients who would have large artery occlusion treated with best medical management (IV-tPA if eligible) and not receiving endovascular therapy will be collected for a secondary analysis as a comparison group and to evaluate the selection methods in them as well
- Day 90 modified Rankin scale [ Time Frame: 90 Days ]Favorable primary clinical outcome will be patients functional outcomes at 90 (+/- 15) days measured by modified Rankin scale (mRS) score 0-2
- Safety (incidence of: hemorrhage; mortality; hematoma, infection, vascular injury) [ Time Frame: 90 Days ]Safety as measured by the incidence rate
- Rates of recanalization [ Time Frame: post-procedure (expected average of 6-12hrs after hospital admittance) ]rates of recanalization (using modified TICI score) will be measured after patient's have undergone endovascular therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446587
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|United States, Florida|
|Orlando, Florida, United States, 32803|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|WellStar Health System|
|Marietta, Georgia, United States, 30066|
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Missouri|
|St. Louis University|
|Saint Louis, Missouri, United States, 78550|
|United States, Ohio|
|Riverside Methodist Hospital|
|Columbus, Ohio, United States, 43214|
|United States, Texas|
|Valley Baptist Medical Center|
|Harlingen, Texas, United States, 78550|
|UTHealth Science Center|
|Houston, Texas, United States, 77030|