Acute ischaemic stroke. CVA. Posterior circulation. Achterste hersencirculatie. Basilar artery occlusion. Arteria basilaris occlusie.
Conditions
Interventions
IV rt-PA:
All patients are treated with a standard full dose of open-label IV rt-PA (0.9mg/kg
90mg
maximum) if standard eligibility criteria are met. Patients treated with IVT within 4.5 hours
of symptom onset, and those who are treated beyond 4.5 hours of symptom onset but
within 4.5 hours of
the Concentric Merci® thrombus-removal device, Penumbra, Solitaire, infusion of rt-PA
combined with an application of low-intensity ultrasound at the site of the occlusion via
the EKOS® Micro-Infusion
Sponsors
BASICS Study Group
Eligibility
Inclusion criteria
Inclusion criteria: 1. Symptoms and signs compatible with ischemia in the basilar artery territory and an NIHSS ≥ 10 at time of randomization; 2. Basilar artery occlusion confirmed by CTA or MRA; 3. Age 18 through 85 years (i.e., candidates must have had their 18th birthday, but not had their 86th birthday); 4. Initiation of IV rt-PA within 4.5 hours of estimated time of basilar artery occlusion (Estimated time of basilar artery occlusion is defined as time of onset of acute symptoms leading to clinical diagnosis of basilar artery occlusion or if not known last time patient was seen normal prior to onset of these symptoms); 5. Initiation of IA therapy should be feasible within 6 hours of estimated time of basilar artery occlusion.
Exclusion criteria
Exclusion criteria: 1. Pre-existing dependency with mRankin ≥3; 2. Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission; 3. Patients who require hemodialysis or peritoneal dialysis; 4. Other serious, advanced, or terminal illness; 5. Any other condition that the investigator feels would pose a significant hazard to the patient if IA therapy is initiated; 6. Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days); 7. Informed consent is not or cannot be obtained. Imaging Exclusion Criteria: 1. Lesion consistent with hemorrhage of any degree; 2. Significant cerebellar mass effect or acute hydrocephalus; 3. Bilateral extended brainstem ischemia.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Excellent outcome at day 90 defined as a modified Rankin Score (mRS – functional scale) of 0-2; 2. Modified Rankin Score – not dichotomized; 3. National Institutes of Health Stroke Scale (NIHSS – acute assessment scale) at time of IVT, at time randomization, at 48 hours post treatment; 4. EQ-5D (quality of life) at day 90 and at 12 months. Radiologic outcomes: 1. Recanalization at 24 hours, ± 6 hours, by CT angiography; 2. Volume of cerebral infarction on NCCT and CTA source images. Safety outcomes: 1. Symptomatic intracranial hemorrhage at 24 hours CT imaging, ± 6 hours; 2. Mortality at 90 days. | — |
Primary
| Measure | Time frame |
|---|---|
| Favourable outcome at day 90 defined as a modified Rankin Score (mRS – functional scale) of 0-3. | — |
Contacts
Public ContactE.J.R.J. Hoeven, van der
Postbus 2500
Outcome results
None listed