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

NCT02446587 | Completed DMC

• 1 other identifier: SELECT
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 9

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.

Conditions

Stroke; Ischemic Stroke

Keywords

endovascular therapy; thrombectomy; selection; imaging; perfusion; collaterals; ASPECTS

Outcome Measures

Primary Outcomes (1)

• Day 90 modified Rankin scale

  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 Outcomes (2)

• Safety (incidence of: hemorrhage; mortality; hematoma, infection, vascular injury)

  90 Days

• Rates of recanalization

  post-procedure (expected average of 6-12hrs after hospital admittance)

Study Arms (2)

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

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

Interventions

Mechanical Thrombectomy DEVICE

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.

Also known as: Endovascular Therapy, Intraarterial Therapy (IAT)

Stroke with Mechanical Thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Stryker Neurovascular: collaborator
• WellStar Health System: collaborator
• AdventHealth: collaborator
• Emory University: collaborator
• Riverside Methodist Hospital: collaborator
• Valley Baptist Medical Center: collaborator
• St. Louis University: collaborator
• University of Kansas: collaborator
• Stanford University: collaborator

Study Sites (9)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

WellStar Health System

Marietta, Georgia, 30066, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

St. Louis University

St Louis, Missouri, 78550, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Valley Baptist Medical Center

Harlingen, Texas, 78550, United States

Location

UTHealth Science Center

Houston, Texas, 77030, United States

Location

Related Publications (6)

• Sarraj A, Albers GW, Mitchell PJ, Hassan AE, Abraham MG, Blackburn S, Sharma G, Yassi N, Kleinig TJ, Shah DG, Wu TY, Hussain MS, Tekle WG, Gutierrez SO, Aghaebrahim AN, Haussen DC, Toth G, Pujara D, Budzik RF, Hicks W, Vora N, Edgell RC, Slavin S, Lechtenberg CG, Maali L, Qureshi A, Rosterman L, Abdulrazzak MA, AlMaghrabi T, Shaker F, Mir O, Arora A, Martin-Schild S, Sitton CW, Churilov L, Gupta R, Lansberg MG, Nogueira RG, Grotta JC, Donnan GA, Davis SM, Campbell BCV; SELECT, EXTEND-IA, EXTEND-IA TNK, and EXTEND-IA TNK Part-II Investigators. Thrombectomy Outcomes With General vs Nongeneral Anesthesia: A Pooled Patient-Level Analysis From the EXTEND-IA Trials and SELECT Study. Neurology. 2023 Jan 17;100(3):e336-e347. doi: 10.1212/WNL.0000000000201384. Epub 2022 Oct 26.

  PMID: 36289001 DERIVED

• Fifi JT, Nguyen TN, Song S, Sharrief A, Pujara DK, Shaker F, Fournier LE, Jones EM, Lechtenberg CG, Slavin SJ, Ifejika NL, Diaz MV, Martin-Schild S, Schaafsma J, Tsai JP, Alexandrov AW, Tjoumakaris SI, Sarraj A; SELECT Investigators. Sex differences in endovascular thrombectomy outcomes in large vessel occlusion: a propensity-matched analysis from the SELECT study. J Neurointerv Surg. 2023 Feb;15(2):105-112. doi: 10.1136/neurintsurg-2021-018348. Epub 2022 Mar 1.

  PMID: 35232756 DERIVED

• Sarraj A, Grotta J, Albers GW, Hassan AE, Blackburn S, Day A, Sitton C, Abraham M, Cai C, Dannenbaum M, Pujara D, Hicks W, Budzik R, Vora N, Arora A, Alenzi B, Tekle WG, Kamal H, Mir O, Barreto AD, Lansberg M, Gupta R, Martin-Schild S, Savitz S, Tsivgoulis G; SELECT Investigators. Clinical and Neuroimaging Outcomes of Direct Thrombectomy vs Bridging Therapy in Large Vessel Occlusion: Analysis of the SELECT Cohort Study. Neurology. 2021 Jun 8;96(23):e2839-e2853. doi: 10.1212/WNL.0000000000012063. Epub 2021 Apr 19.

  PMID: 33875560 DERIVED

• Sarraj A, Hassan AE, Grotta J, Blackburn S, Day A, Abraham M, Sitton C, Dannenbaum M, Cai C, Pujara D, Hicks W, Vora N, Budzik R, Shaker F, Arora A, Riascos RF, Kamal H, Martin-Schild S, Lansberg M, Gupta R, Albers GW; SELECT Investigators. Early Infarct Growth Rate Correlation With Endovascular Thrombectomy Clinical Outcomes: Analysis From the SELECT Study. Stroke. 2021 Jan;52(1):57-69. doi: 10.1161/STROKEAHA.120.030912. Epub 2020 Dec 7.

  PMID: 33280550 DERIVED

• Sarraj A, Pizzo E, Lobotesis K, Grotta JC, Hassan AE, Abraham MG, Blackburn S, Day AL, Dannenbaum MJ, Hicks W, Vora NA, Budzik RF, Sharrief AZ, Martin-Schild S, Sitton CW, Pujara DK, Lansberg MG, Gupta R, Albers GW, Kunz WG; SELECT Investigators. Endovascular thrombectomy in patients with large core ischemic stroke: a cost-effectiveness analysis from the SELECT study. J Neurointerv Surg. 2021 Oct;13(10):875-882. doi: 10.1136/neurintsurg-2020-016766. Epub 2020 Nov 13.

  PMID: 33188155 DERIVED

• Sarraj A, Hassan AE, Grotta J, Sitton C, Cutter G, Cai C, Chen PR, Imam B, Pujara D, Arora A, Reddy S, Parsha K, Riascos RF, Vora N, Abraham M, Edgell R, Hellinger F, Haussen DC, Blackburn S, Kamal H, Barreto AD, Martin-Schild S, Lansberg M, Gupta R, Savitz S, Albers GW. Optimizing Patient Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT): A Prospective, Multicenter Cohort Study of Imaging Selection. Ann Neurol. 2020 Mar;87(3):419-433. doi: 10.1002/ana.25669. Epub 2020 Jan 21.

  PMID: 31916270 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: May 18, 2015
• Study Start: January 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

US (9)