CANVAS 2020.
Study characteristics | ||
Methods | Setting: single‐centre, China Design: RCT, 2 arms, open‐label, blinded endpoint (PROBE) Start date: 5 February 2016 (reported in protocol) Completion date: December 2022 (reported in protocol) |
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Participants | 43 men and women randomised: experimental GA = 21, comparator CSA = 22; procedure interrupted in GA = 8 and CSA = 7; 1 GA and 2 CSA withdrawn due to large infarct and 0 lost to follow‐up was reported, 40 analysed Median age: 65 years (IQR 45–74 years) Gender (men/women): 26/14 Median NIHSS score 13.9 (score range: 10.2–16.0) 4 (18.2%) participants were converted from CSA to GA after randomisation because of significant agitation IV r‐tPA before EVT was not reported Diagnostic criteria: AIS with LVO in anterior cerebral circulation Inclusion criteria
Exclusion criteria
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Interventions | Experimental: GA
Comparator: CSA
Excluded medications: not reported |
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Outcomes | Primary outcome (specified)
Primary outcome (collected)
Secondary outcomes (specified)
Secondary outcomes (collected)
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Notes | Conflict of interest: (quote) "The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article". Funding: (quote) "The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The trial is funded by the Beijing Municipal Administration of Hospitals 'Youth Program' (reference number: QML20150508) and Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support (code number: ZYLX201708)". Protocol: NCT02677415 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomisation occurred when patients were sent to the interventional neuroradiology suite for EVT and were obtained through a purposely built web‐based program, stratified by the site of culprit's vessels (ICA or MCA) using permuted blocks". Comment: method for randomisation was described and seemed appropriate. |
Allocation concealment (selection bias) | Unclear risk | Details were not fully described. Quote: "Patients were randomly allocated to receive either GA or CS in a 1 to 1 ratio". |
Blinding of participants and personnel (performance bias) | High risk | Not described, but due to the nature of the interventions, we assumed that blinding of personnel was not possible. |
Blinding of outcome assessment (detection bias) | Low risk | Quote: "we measured mRS at 90 days by the certified neurologists who were blinded to the group allocation". |
Incomplete outcome data (attrition bias) | High risk | There were no losses. Crossover occurred in 4 (18.2%) participants from CSA to GA group. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported. |
Other bias | Low risk | No evidence of other bias related to this study. |