Zaidat 2015.

Study characteristics
Methods	Multicentre RCT with 1‐year follow‐up
Participants	Estimated sample size: 250 Number randomised: 112 Inclusion criteria Age 18–85 years ≥ 1 symptomatic neurovascular lesion (70%–90% stenosis) Hard TIA or stroke attributable to the territory of the lesion within the past 30 days (specific territories not reported) mRS score ≤3 Exclusion criteria Previous coil or clip placed in territory of target lesion within previous 6 months Myocardial infarction within previous 3 months Treatment with tissue plasminogen activator or other thrombolytic agent within 48 hours prior to randomisation Major surgery or trauma within 2 weeks prior to randomisation > 2 lesions with > 50% stenosis CT or MRI evidence of intracranial haemorrhage, subdural or epidural haemorrhage, or tumour Non‐atherosclerotic stenosis
Interventions	ET plus CMT versus CMT alone
Outcomes	Primary endpoints Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomisation Hard TIA in the same territory (distal to the target lesion) as the presenting event from day 2–month 12 postrandomisation Secondary endpoints Stent success, defined as deployment of the PHAROS Vitesse stent across the target lesion with residual stenosis of 0%–20% Percentage of stent group participants with any (symptomatic or asymptomatic) in‐stent stenosis (≥ 70%) confirmed by angiogram at 12 months Percentage of stent group participants with symptomatic in‐stent restenosis (≥ 70%) confirmed by angiogram at 12 months Percentage of medical therapy group participants with interventional procedure (e.g. angioplasty or stent) at 12 months NIHSS score mRS score
Funding source	Initiated and funded by Micrus Endovascular
Notes	ClinicalTrials.gov identifier: NCT00816166
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients meeting the final enrolment criteria after angiogram were randomly assigned 1:1 to either treatment with medical therapy alone or to medical therapy and PHAROS Vitesse neurovascular stent by a telephonic interactive voice response system (BioClinica Inc, Newtown, PA, USA). Randomisation was stratified by 2 factors: enrolment site and age (18–55 versus 56–85 years)..."
Allocation concealment (selection bias)	Low risk	Quote: "Patients meeting the final enrolment criteria after angiogram were randomly assigned 1:1 to either treatment with medical therapy alone or to medical therapy and PHAROS Vitesse neurovascular stent by a telephonic interactive voice response system (BioClinica Inc, Newtown, PA, USA). Randomisation was stratified by 2 factors: enrolment site and age (18–55 versus 56–85 years)..." 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	Quote: "The current trial was not double‐blinded due to the lack of feasibility of masking the stent group..."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "... end point assessment by an independent neurologist who was not involved in the procedure reduced potential bias..."
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	Although the study was stopped early, the interim analysis showed superiority of CMT over ET and this result was unlikely to change. The industry funding source may be a source of bias.

BI: Barthel Index; CMT: conventional medical treatment; CT: computed tomography; DWI: diffusion‐weighted imaging; ET: endovascular therapy; ITT: intention‐to‐treat; MCA: middle cerebral artery; MoCA: Montreal Cognitive Assessment; mRS: modified Rankin Scale; NIHSS: National Institutes of Health Stroke Scale; PTAS: percutaneous transluminal angioplasty and stenting; RCT: randomised controlled trial; TIA: transient ischaemic attack.