Basilar Artery International Cooperation Study Trial

Phase 3

Completed

Conditions: 10014523
basilar artery obstruction
basilar artery occlusion
10007963
10003184

Registration Number: NL-OMON47335

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

* Symptoms and signs compatible with ischemia in the basilar artery territory
* Basilar artery occlusion confirmed by CTA or MRA.
* Age18 or older (i.e., candidates must have had their 18th birthday).
* If IVT is considered as part of best medical treatment IV rt-PA has to be initiated 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 * this time is not necessarily the same as the time of onset of first symptoms).
* Initiation of IA therapy should be feasible within 6 hours of estimated time of basilar artery occlusion.

Exclusion Criteria

* Pre-existing dependency with mRankin *3.
* Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission.
* Patients who require hemodialysis or peritoneal dialysis.
* Other serious, advanced, or terminal illness.
* Any other condition that the investigator feels would pose a significant hazard to the patient if IA therapy is initiated.
* Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days).
* Informed consent is not or can not be obtained. ;* Imaging Exclusion Criteria:;* Lesion consistent with hemorrhage of any degree.
* Significant cerebellar mass effect or acute hydrocephalus
* Bilateral extended brainstem ischemia.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Favorable outcome at day 90 defined as a modified Rankin Score (mRS *<br /><br>functional scale) of 0-3.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Excellent outcome at day 90 defined as a modified Rankin Score (mRS <br /><br>functional scale) of 0-2.<br /><br>Modified Rankin Score - not dichotomized.<br /><br>Institutes of Health Stroke Scale (NIHSS acute assessment scale) before IVT,<br /><br>before randomization, at 24 hours.<br /><br>EuroQol (quality of life) at day 90 and at 12 months<br /><br><br /><br>Radiologic outcomes:<br /><br>Recanalization at 24 hours, ± 6 hours, by CT angiography.<br /><br>Volume of cerebral infarction on NCCT + CTA-SI.<br /><br><br /><br>Safety outcomes:<br /><br>Symptomatic intracranial hemorrhage at 24 hours CT imaging, ± 6 hours.<br /><br>Mortality at 90 days.</p><br>