Multi Center Clinical trial of endovascular treatment of acute ischemic stroke in the Netherlands.
- Conditions
- brain infarctstroke100079631000318410014523
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 500
*A clinical diagnosis of acute stroke, with a deficit on the NIH stroke scale of more than 2 points.
• CT or MRI scan ruling out intracranial hemorrhage.
• Intracranial arterial occlusion of the distal intracranial carotid artery or middle (M1/M2) or anterior (A1/A2) cerebral artery, demonstrated with CTA, MRA or DSA.
• The possibility to start treatment within 6 hours from onset.
• Informed consent given.
• Age 18 or over.
- cerebral infarction in past 6 weeks
-history in intracerebral bleeding
-RR > 185/110 unresponsive to antihypertensive agents
-blood glucose of < 2.7 or > 22.2
-Clinical signs of hemorrhagic diathesis or platelet count <90 x 10*9/L, APTT>50 sec or INR >1.7
- intravenous treatment with thrombolysis with a dose exceeding 0.9mg/kg or 90 mg
-patients who are treated with intravenous thrombolysis while having cantra-indications for it.;Exclusion criteria for mechanical thrombectomy
- carotid artery stenosis over 70% (NASCETT) which cannot be stented
-RR > 185/110
-Blood glucose < 2.7 or >22.2
-INR > 3.0 or platelet count < 40 x 10*9
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the score on the modified Rankin scale 90 days after<br /><br>inclusion in the study. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Imaging:<br /><br><br /><br>-Vessel recanalization at 24 hours after treatment, assessed by CTA or MRA. The<br /><br>criteria for recanalization on CTA or MRA are based on a modified AOL score and<br /><br>the clot burden score<br /><br>-Infarct size at 24 hours assessed by CT, using standard methods, including<br /><br>manual tracing of the infarct perimeter and semiautomated pixel thresholding.<br /><br>-CTA or MRA at 72 hours will be compared with baseline vessel imaging data, to<br /><br>estimate the recanalization rate. Perfusion CT at baseline is optional, but<br /><br>available at most centers. Infarct size at 24 hours will be compared with plain<br /><br>CT and perfusion CT results at baseline.<br /><br><br /><br><br /><br>Clinical parameters<br /><br>-NIHSS , including NIH supplemental motor score, at 24 hours.<br /><br>-NIHSS at 1 week or at discharge.<br /><br><br /><br>Functional outcome at three months<br /><br>-Barthel<br /><br>-EQ5D</p><br>