SITS (Safe Implementation of Treatments in Stroke) Open Artery by Thrombectomy in Acute Occlusive Stroke Study "SITS Open"


Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria

- Eligible for IV thrombolysis according to clinical guidelines, and IV thrombolysis initiated within 4.5 h after stroke onset.
- Confirmed diagnosis on CTA of persistent occlusion of the proximal Middle Cerebral Artery (M1) or terminal Carotid Artery (Car-T), or Basilar Artery (BA) consistent with the clinical symptoms.
- Baseline NIHSS Score at initiation of IVT is between 7 and 25 for anterior circulation stroke and ≥7 without upper limit for posterior circulation stroke.
- Age ≥18years.
- Anticipated life expectancy of at least 6 months.
- Patient or legal representative is competent to make a decision and has provided informed consent with regard to participation in the study, retrieval and storage of data and follow up procedures.
- Initiation of TBY within 2 hours from IVT (for active arm patients)

Exclusion Criteria

- Fulfilment of any exclusion criteria for IV thrombolysis
- Known significant pre-stroke disability (mRS ≥2)
- Extended early ischemic changes for basilar artery occlusion, according to the judgment of treating physician based on routine clinical practice of the hospital
- Known pregnancy
- Participation in any other investigational drug or device study, currently or in the previous 30 days