Journal article
A randomized controlled trial to optimize patient's selection for endovascular treatment in acute ischemic stroke (SELECT2): Study protocol
International journal of stroke, Vol.17(6), pp.689-693
12/15/2021
DOI: 10.1177/17474930211035032
PMID: 34282987
Abstract
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
Details
- Title: Subtitle
- A randomized controlled trial to optimize patient's selection for endovascular treatment in acute ischemic stroke (SELECT2): Study protocol
- Creators
- Amrou Sarraj - University of Texas McGovern Medical School, Neurology, 6431 Fannin Street, MSB 7.128, Houston, Texas, United States.Ameer E. Hassan - Valley Baptist Medical CenterMichael Abraham - University of Kansas Medical CenterMarc Ribo - Vall d'Hebron Hospital UniversitariSpiros Blackburn - University of Texas McGovern Medical School, Neurosurgery, Houston, Texas, United States.Michael Chen - Rush University Medical CenterMuhammad Shazam Hussain - Cleveland ClinicVitor Mendes Pereira - Toronto Western HospitalSantiago Ortega-Gutierrez - Univ Iowa Hosp, Dept Neurol, Iowa City, IA USAClark Sitton - University of Texas McGovern Medical School, Neuroradiology, Houston, Texas, United States.Phillip W. Lavori - Stanford University, Biomedical Data Science, Stanford, California, United States.Chunyan Cai - University of Texas McGovern Medical School, Clinical and Translational Science, Houston, Texas, United States.Mohammed Rahbar - UT McGovern Med Sch, CCTS, Houston, TX 77030 USADeep Pujara - University of Texas McGovern Medical School, Neurology, 6431 Fannin St, MSB 7.039, Houston, Texas, United States.Faris Shaker - The University of Texas at AustinMaarten G. Lansberg - Stanford UniversityBruce Campbell - Royal Melbourne Hosp, Dept Neurol, Parkville, Vic, AustraliaJames C. Grotta - Memorial Hermann Texas Medical CenterGregory W. Albers - Stanford UniversitySELECT2 Investigators
- Resource Type
- Journal article
- Publication Details
- International journal of stroke, Vol.17(6), pp.689-693
- DOI
- 10.1177/17474930211035032
- PMID
- 34282987
- NLM abbreviation
- Int J Stroke
- ISSN
- 1747-4930
- eISSN
- 1747-4949
- Publisher
- Sage
- Number of pages
- 5
- Grant note
- Stryker Neurovascular
- Language
- English
- Date published
- 12/15/2021
- Academic Unit
- Neurology; Radiology; Iowa Neuroscience Institute; Neurosurgery
- Record Identifier
- 9984303012502771
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