Perfusion-CT guided intravenous thrombolysis at 3 to 6 hours: feasibility and safety study

Recruiting

Phase N/A Results N/A

Trial Description

To determine the feasibility and safety of using a newly developed perfusion-CT-software to select patients with a favorable penumbra/core-ratio for intravenous thrombolysis in the 3 to 6 hour window after onset of acute ischemic stroke.

Interventions

Trial Design

To be included, the patients need to have a minimal penumbra size for a given core (infarct) size on the perfusion-CT, according to a progressive linear cut-off table. The cut-off values were selected for maximal potential benefit: the smaller the core size is (and thus the smaller the theoretical bleeding risk), the smaller the penumbra must be to for inclusion. The maximal upper size for inclusion is a core of 30% of the MCA territory (where penumbra must be at least 60%). The trial will be stopped after 4 symptomatic hemorrhages or after 12 patients are enrolled.

Patient Involvement

Treatment modalities, exclusion criteria and blood pressure management are identical to the ones in the NINDS rt-PA for Acute Ischemic Stroke Trial except for the 3 to 6 hour window.

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary endpoints are symptomatic intracranial hemorrhages at 24 hours and mortality at 7 and 90 days.
Secondary Secondary endpoints are independence at 90 days (mRS 0-2), Barthel index at 90 days, NIHSS at 24 hours, 7 and 90 days, final infarct size, and recanalisation rate at 24 hours by angio-CT.