A randomized controlled trial to optimize patient’s selection for endovascular treatment in acute ischemic stroke (SELECT2): Study protocol

You can see from the start of this research they have the wrong outcome measurements, mRS 0 or 1 should be the only measures needed, anything else should be considered failure. Unless failure is acknowledged it will NEVER BE FIXED. This just normalizes failure.

0  The patient has no residual symptoms.

1  The patient has no significant disability; able to carry out all pre-stroke activities.

2  The patient has slight disability; unable to carry out all pre-stroke activities but able to look after self without daily help.

3  The patient has moderate disability; requiring some external help but able to walk without the assistance of another individual.

4  The patient has moderately severe disability; unable to walk or attend to bodily functions without assistance of another individual.

5  The patient has severe disability; bedridden, incontinent, requires continuous care.

6  The patient has expired (during the hospital stay or after discharge from the hospital).

A randomized controlled trial to optimize patient’s selection for endovascular treatment in acute ischemic stroke (SELECT2): Study protocol

Amrou Sarrajhttps://orcid.org/0000-0001-5726-44781, Ameer E Hassanhttps://orcid.org/0000-0002-7148-76162, Michael Abraham3, Marc Ribo4, Spiros Blackburn5, Michael Chen6, Muhammad Shazam Hussain7, Vitor Mendes Pereira8, Santiago Ortega-Gutierrez9, Clark Sitton10, Phillip W Lavori11, Chunyan Cai12, Mohammed Rahbar12, Deep Pujarahttps://orcid.org/0000-0001-6187-894X1, Faris Shakerhttps://orcid.org/0000-0003-4462-52321, Maarten G Lansberghttps://orcid.org/0000-0002-3545-692713, Bruce Campbellhttps://orcid.org/0000-0003-3632-943314, James C Grotta15, Gregory W Albers13, and on behalf of the SELECT2 Investigators
Rationale

Randomized evidence for endovascular thrombectomy safety and efficacy in patients with large core strokes is lacking.
Aims

To demonstrate endovascular thrombectomy efficacy and safety in patients with large core on non-contrast CT or perfusion imaging (CT/MR) and determine if there is heterogeneity of treatment effect in large cores based on the imaging modality.
Design

SELECT2 is a prospective, randomized, multi-center, assessor-blinded controlled trial with adaptive enrichment design, enrolling up to 560 patients.
Procedure

Patients who meet the clinical criteria and have anterior circulation large vessel occlusions with large core on either NCCT (ASPECTS 3–5) or perfusion imaging (CTP [rCBF < 30%] and/or MRI [ADC < 620] ≥ 50 cc) will be randomized in a 1:1 ratio to undergo endovascular thrombectomy or medical management (MM) only up to 24 h of last known well.
Study outcomes

The distribution of 90-day mRS scores is the primary outcome. Functional independence (mRS = 0–2) rate is a secondary outcome. Other secondary outcomes include safety (symptomatic ICH, neurological worsening, mortality) and imaging outcomes.
Analysis

A normal approximation of the Wilcoxon-Mann-Whitney test (the generalized likelihood ratio test) to assess the primary outcome. Functional independence rates, safety and imaging outcomes will also be compared.
Discussion

The SELECT2 trial will evaluate endovascular thrombectomy safety and efficacy in large cores on either CT or perfusion imaging and may provide randomized evidence to extend endovascular thrombectomy eligibility to larger population.
Registration: ClinicalTrials.gov–NCT03876457
Keywords
Acute stroke therapy, thrombectomy, clinical trial, large vessel occlusion, ischemic stroke, protocols
1Department of Neurology, UT McGovern Medical School, Houston, USA
2Department of Neurology, Valley Baptist Medical Center, Harlingen, USA
3Department of Neurology, University of Kansas Medical Center, Kansas City, USA
4Department of Neurology, Vall d'Hebron Hospital Universitari, Barcelona, Spain
5Department of Neurosurgery, UT McGovern Medical School, Houston, USA
6Department of Neurosurgery, Rush University, Chicago, USA
7Department of Neurology, Cleveland Clinic, Cleveland, USA
8Department of Neurology, Toronto Western Hospital, Toronto, Canada
9Department of Neurology, University of Iowa Hospitals, Iowa City, USA
10Department of Neuroradiology, UT McGovern Medical School, Houston, USA
11Biomedical Data Science, Stanford University, Stanford, USA
12CCTS, UT McGovern Medical School, Houston, USA
13Department of Neurology, Stanford University, Stanford, USA
14Department of Neurology, Royal Melbourne Hospital, Parkville, Australia
15Department of Neurology, Memorial Hermann–Texas Medical Center, Houston, USA
*Investigators listed in eTable 3.
Corresponding author(s):
Amrou Sarraj, UT McGovern Medical School, 6431 Fannin St #7.044; Houston, TX 77030, USA. Email: Amrou.Sarraj@uth.tmc.edu