Amrou Sarraj1, Ameer E Hassan2, 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 Pujara1, Faris Shaker1, Maarten G Lansberg13, Bruce Campbell14, James C Grotta15, Gregory W Albers13. 1. Department of Neurology, UT McGovern Medical School, Houston, USA. 2. Department of Neurology, Valley Baptist Medical Center, Harlingen, USA. 3. Department of Neurology, University of Kansas Medical Center, Kansas City, USA. 4. Department of Neurology, Vall d'Hebron Hospital Universitari, Barcelona, Spain. 5. Department of Neurosurgery, UT McGovern Medical School, Houston, USA. 6. Department of Neurosurgery, Rush University, Chicago, USA. 7. Department of Neurology, Cleveland Clinic, Cleveland, USA. 8. Department of Neurology, Toronto Western Hospital, Toronto, Canada. 9. Department of Neurology, University of Iowa Hospitals, Iowa City, USA. 10. Department of Neuroradiology, UT McGovern Medical School, Houston, USA. 11. Biomedical Data Science, Stanford University, Stanford, USA. 12. CCTS, UT McGovern Medical School, Houston, USA. 13. Department of Neurology, Stanford University, Stanford, USA. 14. Department of Neurology, Royal Melbourne Hospital, Parkville, Australia. 15. Department of Neurology, Memorial Hermann-Texas Medical Center, Houston, USA.
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.
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.
Authors: Robert W Regenhardt; Amine Awad; Andrew W Kraft; Joseph A Rosenthal; Adam A Dmytriw; Justin E Vranic; Anna K Bonkhoff; Martin Bretzner; Mark R Etherton; Joshua A Hirsch; James D Rabinov; Aneesh B Singhal; Natalia S Rost; Christopher J Stapleton; Thabele M Leslie-Mazwi; Aman B Patel Journal: Stroke Vasc Interv Neurol Date: 2022-05-20
Authors: Laurens Winkelmeier; Gabriel Broocks; Helge Kniep; Vincent Geest; Jonathan Reinwald; Lukas Meyer; Noel van Horn; Adrien Guenego; Kamil Zeleňák; Gregory W Albers; Maarten Lansberg; Peter Sporns; Max Wintermark; Jens Fiehler; Jeremy J Heit; Tobias D Faizy Journal: J Stroke Date: 2022-09-30 Impact factor: 8.632