Swiss Intravenous and Intra-arterial Thrombolysis for Treatment of Acute Ischemic Stroke Registry
Swiss Intravenous and Intra-arterial Thrombolysis for Treatment of Acute Ischemic Stroke Registry
The clinical and radiological data of patients with an acute ischemic stroke treated with
 intravenous thrombolysis (IVT) or intraarterial thrombolysis (IAT) in a Swiss stroke unit are
 assessed in a Swiss Multicenter Thrombolysis Registry. Like in clinical routine, a clinical
 evaluation takes place in a 3-months follow-up. Furthermore quality of life is assessed with
 a standardized questionnaire. The aim of the registry is to compare the safety and efficacy
 of IVT and IAT in patients with acute ischemic stroke. The registry also helps to improve
 in-hospital-management of stroke patients.
Background: Intravenous thrombolysis (IVT) and intra-arterial thrombolysis (IAT) have been
 shown to be effective treatments for acute stroke in controlled randomized trials and
 meta-analyses. However, prospective studies comparing IVT and IAT have not been performed,
 and it is not known which patients benefit more from IVT or IAT. Non-invasive neurovascular
 imaging techniques such as magnetic resonance angiography (MRA) or computed tomography
 angiography (CTA) have the potential to improve patient selection for the optimal mode of
 thrombolytic therapy and provide data of pre-treatment neurovascular findings of patients
 treated with IVT. IAT series have identified several prognostic factors for favourable or
 poor outcome predictors such as vessel recanalization, location of the vascular occlusion or
 NIHSS at admission. Additional studies have shown that recanalization rates in patients with
 central ves-sel occlusions such as middle cerebral artery (MCA) main stem or MCA main branch
 or basilar artery (BA) is higher when treated with IAT compared to IVT. Therefore, the
 investigators hypothesize that IAT might be more efficacious in these patients.

 Objective: Prospective observational multicenter registry with the following aims: To compare
 the safety and efficacy of IAT and IVT in patients with acute ischemic stroke. To improve
 safety of IAT and IVT by monitoring the in-hospital management.

 Methods: Consecutive patients with acute ischemic stroke who are treated with IVT or IAT
 within 6 hours of symptom onset in a Swiss stroke unit will be eligible for this registry.
 Patients are given either intravenous rt-PA or receive IAT such as intra-arterial urokinase,
 intra-arterial rt-PA or mechanical endovascular recanalization techniques. Patient
 involvement in the registry shall not influence any treatment decision. Patients will undergo
 a complete diagnostic work up including a clinical neurological examination using the
 National Institutes of Health Stroke Scale (NIHSS) score on admission, laboratory
 examination, brain and neurovascular imaging, echocardiography, 24-hours ECG to determine
 stroke etiology using the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria. The
 treating physician will initiate secondary prevention of stroke as soon as possible. All
 patients will be examined by CT and CTA or MRI and MRA on day 1 and in any case of clinical
 deterioration to exclude intracranial haemorrhage and to assess recanalization of the
 occluded vessel (using the thrombolysis in myocardial infarction (TIMI) grading system).
 Clinical outcome will be evaluated on day 1 and at 3 months using the National Institute of
 Health Stroke Scale (NIHSS) score, modified Rankin Scale score (mRS), Barthel Index (BI), and
 assessing adverse events and quality of life. The proportion of patients with favourable
 outcome (mRS 0 to 2) at 3 months after IVT and IAT will serve as the primary outcome measure.
 In addition, subgroup analyses will be performed stratified by NIHSS, location of vessel
 occlusion, time to hospital admission and time to treatment. Secondary outcome measures will
 include quality of life and the proportion of patients with an excellent outcome (mRS 0 or 1)
 at 3 months, BI 75 to 100 at 3 months, mortality at 3 months, rapid neurological improvement
 during the first 24 hours, complete or partial recanalization, and symptomatic intracranial
 haemorrhage.
Inclusion Criteria:

 -  Age ≥ 18 years

 -  Intracranial arterial occlusion confirmed by conventional angiography, MRA or CTA

 -  National Institute of health Stroke Scale (NIHSS) score ≥ 4 or isolated aphasia or
 hemianopia

 -  Time to treatment < 6 hours

 Exclusion Criteria

 -  Intracranial haemorrhage on CT scn or MRI

 -  History of intracranial haemorrhage or subarachnoid haemorrhage

 -  Platelet count < 100'000

 -  International normalized ration (INR) > 1.5

 -  Partial thromboplastin time (PTT) > 1.5 times the normal value

 -  Known hereditary of acquired haemorrhagic diathesis

 -  Pre-existing neurological deficit (mRS>2)

 -  Previous stroke that might interfere with the neurological assessment (mRS >2)

 -  Active gastric ulcer

 -  Major trauma within the preceding 3 months

 -  Major surgery within the past 4 weeks

 -  Childbirth within the previous 4 weeks

 -  Pregnancy

 -  Uncontrolled hypertension (>185/10 on repeated measures despite antihypertensive
 medication)

 -  Severe systemic disease with poor prognosis (e.g. cancer, severe heart failure)

 -  Intracranial neoplasm

 -  Combined IVT and IAT

 -  Combined Intravenous and Ultrasound Thrombolysis