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

Miao 2012.

Study characteristics
Methods Single‐centre RCT with 1‐year follow‐up
Participants Estimated sample size: 184
Number randomised: 70
Inclusion criteria
  • Age 25–75 years

  • TIA or stroke in the territory of unilateral MCA stenosis

  • 70%–99% stenosis with stenotic length < 10 mm and distal vessel diameter > 2 mm. 

  • mRS score < 3

  • NIHSS score < 15


Exclusion criteria
  • Acute stroke in the target territory in previous 3 weeks

  • Tandem ≥ 50% stenosis of target MCA

  • Prior angioplasty or stenting at the target vessel

  • Thrombolysis treatment within 24 hours before randomisation

  • Non‐atherosclerotic stenosis

Interventions ET plus CMT versus CMT alone
Outcomes Primary outcomes 
  • Ipsilateral stroke, TIA, or death at 30 days and 1 year


Secondary outcomes
  • None

Funding source Funded by the Research Fund of Capital Medical Development (2007–2069).
Notes Clinical Trial Registration URL: www.chictr.org/en/
Unique identifier: ChiCTR‐TRC‐12001989
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The randomisation numbers were produced by Randlist software (Version 1.2 \Seed: [1497369600]; http://www.randomisation.net), 4 numbers as a block."
Allocation concealment (selection bias) Low risk Quote: "Patients were randomised to either the PTAS or medical group."
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: "Investigators who did not participate in the enrolment of the patients and were blinded to the treatment assignment..."
Incomplete outcome data (attrition bias)
All outcomes High risk There was a high rate of loss to 1‐year follow‐up (49/70, 30%), and 19.4% of participants randomised to the ET group refused ET.
Selective reporting (reporting bias) Low risk All study outcomes were prespecified in the registered information.
Other bias High risk The study was stopped early; results of an interim analysis showed similar safety and efficacy for CMT and ET. However, the final results could have changed if recruitment had continued.