Gao 2022.
Study characteristics | ||
Methods | Multicentre, randomised, open‐label, outcome assessor‐blinded trial with 3‐year follow‐up | |
Participants | Estimated sample size: 380 Number randomised: 380 Inclusion criteria:
Exclusion criteria
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Interventions | ET plus CMT versus CMT alone | |
Outcomes | Primary endpoints
Secondary endpoints
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Funding source | Funded by a research grant (2011BAI08B04) from the National Health Commission of the People's Republic of China. Stryker Neurovascular provided supplemental funding for third‐party site monitoring and auditing. | |
Notes | ClinicalTrials.gov Identifier: NCT01763320 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "IVRS (Interactive Voice Response System, Clinicalsoft Company Limited) will be used for patient randomization." |
Allocation concealment (selection bias) | Low risk | Quote: "Patients meeting the inclusion criteria will be randomized (1:1) to medical therapy alone or medical therapy plus stenting using Wingspan." Comment: the study used software that carried out allocations in a closed environment, and nobody knew the allocation until after enrolment had been confirmed. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | As the 2 treatments were very different, blinding of participants and personnel was not possible. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "An imaging database was established to facilitate central reading by an independent imaging core lab (IsCore Image Corelab)." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Incomplete outcome data adequately resolved and unlikely to seriously alter the results with ITT analysis. |
Selective reporting (reporting bias) | Low risk | All study outcomes were prespecified in the published protocol. |
Other bias | High risk | The industry funding source may be a source of bias |