EUCTR2009-017315-15-NL
Active, not recruiting
Not Applicable
Multi Center Clinical trial of endovascular treatment of acute ischemic stroke in the Netherlands. - MR CLEA
Erasmus MC Rotterdam0 sitesJune 11, 2010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute ischemic brain infarction
- Sponsor
- Erasmus MC Rotterdam
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\*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, DSA or transcranial Doppler/duplex (TCD).
- •The possibility to start treatment within 6 hours from onset.
- •Informed consent given.
- •Age 18 or over.
- •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 250
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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