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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
Sponsor:
Collaborators:
Stryker Neurovascular
WellStar Health System
Florida Hospital
Emory University
Riverside Methodist Hospital
Valley Baptist Medical Center
St. Louis University
University of Kansas
Stanford University
Information provided by (Responsible Party):
Amrou Sarraj, The University of Texas Health Science Center, Houston

Brief Summary:

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

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. 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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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.
Other Names:
  • Endovascular Therapy
  • Intraarterial Therapy (IAT)

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Safety (incidence of: hemorrhage; mortality; hematoma, infection, vascular injury) [ Time Frame: 90 Days ]
    Safety as measured by the incidence rate

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study 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
Criteria

Inclusion Criteria:

Eligible patients will be:

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

Exclusion Criteria:

Patients are excluded if:

  1. Inability to undergo CT-Angiography and/or CT-Perfusion imaging (e.g., renal insufficiency, iodine/contrast allergy)
  2. Co-morbid psychiatric or medical illnesses that would confound the neurological assessments
  3. 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.

Information from the National Library of Medicine

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


Locations
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United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
United States, Georgia
Emory University
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
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Stryker Neurovascular
WellStar Health System
Florida Hospital
Emory University
Riverside Methodist Hospital
Valley Baptist Medical Center
St. Louis University
University of Kansas
Stanford University

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Responsible Party: Amrou Sarraj, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02446587     History of Changes
Other Study ID Numbers: SELECT
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

Keywords provided by Amrou Sarraj, The University of Texas Health Science Center, Houston:
endovascular therapy
thrombectomy
selection
imaging
perfusion
collaterals
ASPECTS

Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia