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

April 15, 2019 updated by: Amrou Sarraj, The University of Texas Health Science Center, Houston

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Florida
      • Orlando, Florida, United States, 32803
        • Florida Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Marietta, Georgia, United States, 30066
        • Wellstar Health System
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 78550
        • St. Louis University
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
    • Texas
      • Harlingen, Texas, United States, 78550
        • Valley Baptist Medical Center
      • Houston, Texas, United States, 77030
        • UTHealth Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (incidence of: hemorrhage; mortality; hematoma, infection, vascular injury)
Time Frame: 90 Days
Safety as measured by the incidence rate
90 Days
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
post-procedure (expected average of 6-12hrs after hospital admittance)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Emory University
Stanford University
Stryker Neurovascular
AdventHealth
University of Kansas
St. Louis University
WellStar Health System
Riverside Methodist Hospital
Valley Baptist Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

May 8, 2015

First Submitted That Met QC Criteria

May 15, 2015

First Posted (Estimate)

May 18, 2015

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SELECT (Other Identifier: Folktandvården Stockholms län AB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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