Vienna Interventional Management of Stroke Study

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Age between 18 – 80 years
•Clinical syndrome of a severe ischemic lesion within the anterior circulation („Total Anterior Circulation Syndrome TACS) or of basilar artery occlusion
•NIHSS > 12
•Start of IVT within 3 hours („bridging, „rescue) or within 4.5 hours (`primary endovascular management`)
•Confirmation of proximal occlusion
•Absence of exclusion criteria

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

•History of stroke within the last 3 months
•History of subarachnoid or intracranial hemorrhage, known cerebrovascular arteriovenous malformation or CNS tumour
•Clinical suggestion of subarachnoid hemorrhage and negative CT
•Uncontrolled systolic blood pressure
•Evidence of septic embolism etiologically related to stroke
•Evidence of pericarditis including pericarditis after myocardial infarction
•Operation or biopsy of a body organ within the last 30 days (not an exclusion criterion for primary endovascular treatment)
•Trauma with inner or outer ulcerous wounds within the last 30 days (not an exclusion criterion for primary endovascular treatment)
•Severe head trauma or concussion within the last 90 days
•Current bleeding
•Systemic bleeding (outside the head) within the last 30 days (not an exclusion criterion for primary endovascular treatment)
•Known hereditary or acquired hemorrhagic diathesis , known hereditary or acquired coagulation factor deficiency; oral anticoagulation and a prolonged prothrombin time (INR > 1.5)
•Women of childbearing age with known pregnancy or positive pregnancy test
•Baseline platelet count < 100,000/mm or haematocrit < 25%
•Patients on treatment with unfractioned heparin within the last 48 hours and prolonged partial thromboplastin time exceeding the upper limit of the local laboratory normal range
•Arterial puncture at a non-compressible site or spinal tab within the past 7 days (not an exclusion criterion for primary endovascular treatment)
•Uncertainty if neurological deficit is caused by vessel occlusion, e.g. after an epileptic seizure or neurologic/psychiatric illness
•Known severe progressive or terminal illness
•Any other reason that, in the opinion of the investigator, would bear a risk for rt-PA treatment

Imaging exclusion criteria:
CT-criteria:
•any hemorrhage
•edema with mass effect and midline shift
•extensive hypodensity (> 1/3 of MCA territory)
MR-criteria:
•Extensive diffusion lesion (> 1/3 of MCA territory)
•No mismatch (at the discretion of treating neurologists/radiologists)