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. 2021 Dec 1;2021(12):CD010995. doi: 10.1002/14651858.CD010995.pub3

NCT04256096.

Study name Randomization of Endovascular Treatment in Acute Ischemic Stroke in the Extended Time Window (RESILIENTExt)
Methods A phase III, randomised, multicentre, open‐label clinical trial that will examine whether endovascular treatment is superior to standard medical therapy alone in patients who suffer a large vessel anterior circulation ischaemic stroke within 8 to 24 hours from time last seen well
Participants
  • Acute ischaemic stroke where patient is ineligible for IV thrombolytic treatment, or the treatment is contraindicated (e.g. patient presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without clinical improvement

  • No significant pre‐stroke functional disability (mRS ≤ 2)

  • Baseline NIHSS score obtained prior to randomisation must be ≥ 8 points (assessed within 1 hour prior to qualifying imaging)

  • Age ≥ 18 years (no upper age limit)

  • Occlusion (TICI 0 to 1) of the intracranial ICA (distal ICA or T occlusions) and/or MCA‐M1 segment suitable for endovascular treatment, as evidenced by CTA, MRA, or angiogram, with or without concomitant cervical carotid occlusion or stenosis

  • Patient treatable within 6 to 24 hours of symptom onset. Symptom onset is defined as point in time the patient was last seen well (at baseline). Treatment start is defined as arterial puncture.

  • Informed consent obtained from patient or acceptable patient surrogate

  • Estimated enrolment is 376 participants

Interventions Endovascular treatment of large vessel occlusion (mechanical thrombectomy) with stent‐retriever and/or thromboaspiration (neurointerventionalist choice)
Outcomes Distribution of the mRS scores at 90 days (shift analysis). The score ranges from 0 to 6, with higher values indicating a worst functional outcome at 90 days.
Starting date 9 March 2020
Contact information Sheila CO Martins MD, PhD
Notes ClinicalTrials.gov identifier: NCT04256096

aPTT: activated partial thromboplastin time
ASPECTS: Alberta Stroke Program Early Computed Tomography Score
CT: computed tomography
CTA: Computed tomography angiography
DWI: diffusion‐weighted imaging
FLAIR: fluid attenuated inversion recovery
ICA: internal carotid artery
INR: international normalised ratio
IST‐3: International Stroke Trial‐3
IV: intravenous
MCA: middle cerebral artery
MMSE: Mini‐Mental State Exam
MRA: magnetic resonance angiogram
MRI: magnetic resonance imaging
mRS: modified Rankin Scale
NIHSS: National Institutes of Health Stroke Scale
PWI: perfusion‐weighted imaging
SITS‐MOST: Safe Implementation of Thrombolysis in Stroke‐Monitoring Study
TICI: thrombolysis in cerebral infarction