Back to Search
Start Over
A randomized controlled trial to optimize patient's selection for endovascular treatment in acute ischemic stroke (SELECT2): Study protocol
- Source :
- International journal of stroke : official journal of the International Stroke Society. 17(6)
- Publication Year :
- 2021
-
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 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
- Subjects :
- medicine.medical_specialty
Comparative effectiveness research
law.invention
Brain Ischemia
Patient safety
Randomized controlled trial
law
Medicine
Humans
Multicenter Studies as Topic
Prospective Studies
Stroke
Ischemic Stroke
Randomized Controlled Trials as Topic
Thrombectomy
Protocol (science)
business.industry
Cerebral infarction
Patient Selection
Endovascular Procedures
medicine.disease
Clinical trial
Clinical research
Treatment Outcome
Neurology
Emergency medicine
business
Subjects
Details
- ISSN :
- 17474949
- Volume :
- 17
- Issue :
- 6
- Database :
- OpenAIRE
- Journal :
- International journal of stroke : official journal of the International Stroke Society
- Accession number :
- edsair.doi.dedup.....ada06a248f730b049a22974d8bc66afd