Table 1

Summary of study assessments

Study requirementsScreening and baselineRecanalisation procedure24 hours (−6/+12 hours) post-treatmentFollow-up visits
Prior to start of study treatmentPreprocedureIntraprocedureImmediately postprocedureHospital discharge or 7 (±3) days90 (±14) days
(76–104 days)
Informed consentX
Clinical assessment, vital signs and physical examXXXXX
Laboratory testsX
Subject identification number assignment (assigned at time of ICF)X
NIHSS (blinded to treatment)XXX
mRS (blinded to treatment)XXX
EQ-5D (blinded to treatment)X
Relevant concomitant medicationsXXXXXXX
Treatment medicationsXXXX
Inclusion imaging for ICH and ASPECTS (MRI or CT/CTP as per institutional standard)X
eTICI assessmentXXX
Non-enhanced CT or FLAIR/T2WI post treatment (according to standard of care)X
CTA or MRA post treatment (according to standard of care)X
Serious adverse eventsXXXXXX
Protocol deviationsXXXXXX
Subject evaluation for study terminationXXXXXX
  • ASPECTS, Alberta Stroke Program Early CT Score; CTA, computed tomography angiography; EQ-5D, EuroQol Five Dimensions Questionnaire; eTICI, expanded Thrombolysis In Cerebral Infarction Score; FLAIR, fluid attenuated inversion recovery; ICF, informed consent form; ICH, intracranial haemorrhage; MRA, magnetic resonance angiography; mRS, modified Rankin Scale; NIHSS, National Institute of Health Stroke Scale; T2WI, T2 weighted imaging.