Multi Center Clinical trial of endovascular treatment of acute ischemic stroke in the Netherlands.

• Conditions: Acute ischemic brain infarction; MedDRA version: 17.0Level: LLTClassification code 10023027Term: Ischaemic stroke NOSSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2009-017315-15-NL
• Lead Sponsor: Erasmus MC Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-11
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 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
-Blood glucose < 2.7 or >22.2
-INR > 3.0 or platelet count < 40 x 10*9

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified