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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Completed

CT.gov ID

NCT02446587

Collaborator

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

500

Enrollment

Locations

Actual Duration (Months)

55.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Jan 1, 2016

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

May 1, 2018

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Day 90 modified Rankin scale [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

Safety (incidence of: hemorrhage; mortality; hematoma, infection, vascular injury) [90 Days]
Safety as measured by the incidence rate
Rates of recanalization [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Medical Center	Stanford	California	United States	94305
2	Florida Hospital	Orlando	Florida	United States	32803
3	Emory University	Atlanta	Georgia	United States	30322
4	WellStar Health System	Marietta	Georgia	United States	30066
5	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
6	St. Louis University	Saint Louis	Missouri	United States	78550
7	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
8	Valley Baptist Medical Center	Harlingen	Texas	United States	78550
9	UTHealth Science Center	Houston	Texas	United States	77030