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. 2023 Feb 3;2023(2):CD013267. doi: 10.1002/14651858.CD013267.pub3

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:
  • Age 30–80 years

  • TIA or non‐disabling ischaemic stroke (mRS < 3) within past 12 months

  • Target vessel reference diameter 2.00 mm–4.50 mm; target stenosis < 14 mm in length.

  • Intracranial stenosis (70%–99%) of a major intracranial artery supplying the territory of the ischaemic event. 


Exclusion criteria
  • Brainstem or basal ganglia perforator stroke (identified by DWI)

  • < 3 weeks from latest ischaemic symptom onset

  • Tandem extracranial or intracranial stenosis (70%–99%) or occlusion that is proximal or distal to the target intracranial lesion

  • Bilateral intracranial vertebral artery stenosis of 70%–99% and uncertainty about which lesion is symptomatic

  • Presence of a previously placed intravascular stent or graft in the ipsilateral distribution within 30 days

  • Plan to perform concomitant angioplasty or stenting of an extracranial vessel tandem to an ipsilateral intracranial stenosis

  • Presence of intraluminal thrombus proximal to or at the target lesion

  • Intracranial tumours or any intracranial vascular malformations

  • Any aneurysm proximal to or distal to intracranial stenotic artery

  • CT or angiographic evidence of severe calcification at target lesion

  • Thrombolytic therapy within 24 hours before enrolment

  • Thrombolytic therapy within 24 hours before enrolment

  • Stroke of sufficient size (> 5 cm on CT or MRI) to place patient at risk of hemorrhagic transformation during the procedure; hemorrhagic transformation of an ischaemic stroke within previous 15 days

  • Previous spontaneous intracerebral (parenchymal) or other intracranial (subarachnoid, subdural, or epidural) haemorrhage within previous 30 days

  • Untreated chronic subdural haematoma > 5 mm in thickness

  • Myocardial infarction within previous 30 days

Interventions ET plus CMT versus CMT alone
Outcomes Primary endpoints
  • Stroke and death within 30 days after enrolment

  • Stroke in the territory of qualifying artery beyond 30 days through 1 year


Secondary endpoints
  • Disabling stroke or death after enrolment within 3 years

  • Stroke in the qualifying artery territory within 2 years

  • Stroke in the qualifying artery territory within 3 years

  • Any stroke, TIA, or cardiovascular events within 3 years

  • Death within 3 years

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