Summary of study assessments
| Study requirements | Screening and baseline | Recanalisation procedure | 24 hours (−6/+12 hours) post-treatment | Follow-up visits | |||
| Prior to start of study treatment | Preprocedure | Intraprocedure | Immediately postprocedure | Hospital discharge or 7 (±3) days | 90 (±14) days (76–104 days) | ||
| Inclusion/exclusion | X | X | |||||
| Informed consent | X | ||||||
| Clinical assessment, vital signs and physical exam | X | X | X | X | X | ||
| Laboratory tests | X | ||||||
| Subject identification number assignment (assigned at time of ICF) | X | ||||||
| Randomisation | X | ||||||
| NIHSS (blinded to treatment) | X | X | X | ||||
| mRS (blinded to treatment) | X | X | X | ||||
| EQ-5D (blinded to treatment) | X | ||||||
| Relevant concomitant medications | X | X | X | X | X | X | X |
| Treatment medications | X | X | X | X | |||
| Inclusion imaging for ICH and ASPECTS (MRI or CT/CTP as per institutional standard) | X | ||||||
| eTICI assessment | X | X | X | ||||
| 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 events | X | X | X | X | X | X | |
| Protocol deviations | X | X | X | X | X | X | |
| Subject evaluation for study termination | X | X | X | X | X | X | |
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.