Acute Stroke Clinical Trial
— ENDOSTROKEOfficial title:
International Multicenter Registry for Mechanical Recanalization Procedures in Acute Stroke (ENDOSTROKE)
NCT number | NCT01399762 |
Other study ID # | Endostroke_01 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | July 18, 2011 |
Last updated | July 21, 2011 |
Start date | January 2011 |
The purpose of the Endostroke Registry is to gather information on predictors of good or poor clinical outcome following mechanical recanalization therapies for acute ischemic stroke.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients being treated with mechanical recanalization devices due to an acute proximal arterial vessel occlusion of brain supplying arteries Exclusion Criteria: - Patients being treated with mechanical recanalization devices for venous vessel occlusion. - Patients being treated with mechanical recanalization devices due to an acute vessel occlusion which occured as a complication of an angiographic procedure scheduled for other reasons (i.e. as a complication of a diagnostic angiography or coiling procedure for cerebral aneurysms) |
Observational Model: Cohort
Country | Name | City | State |
---|---|---|---|
Austria | Departments of Neurology and Neuroradiology, University Hospital | Graz | |
Austria | Departments of Neurology and Neuroradiology, Landes-Nervenklinik Wagner-Jauregg | Linz | |
Germany | Departments of Neurology and Neuroradiology, University Hospital | Aachen | |
Germany | Departments of Neurology and Radiology, Klinikum Altenburger Land | Altenburg | |
Germany | Departments of Neurology and Neuroradiology, Charite University Hospital | Berlin | |
Germany | Departments of Neurology and Neuroradiology, University Hospital | Duesseldorf | |
Germany | Departments of Neurology and Neuroradiology, University Hospital | Essen | |
Germany | Hirngefaesszentrum Goethe University | Frankfurt | |
Germany | Departments of Neurology and Neuroradiology, Klinikum Fulda | Fulda | |
Germany | Departments of Neurology and Neuroradiology, University Hospital | Giessen | |
Germany | Departments of Neurology and Neuroradiology, University Hospital | Kiel | |
Germany | Departments of Neurology and Neuroradiology, University Hospital | Mainz | |
Germany | Departments of Neurology and Neuroradiology, Knappschaftskrankenhaus | Recklinghausen |
Lead Sponsor | Collaborator |
---|---|
Goethe University |
Austria, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical outcome | Proportion of patients with favourable clinical outcome defined as a Modified Rankin Score (MRS) of 0,1, or 2 three months after the intervention. | approx. 90 days after stroke onset | No |
Secondary | Angiographic outcome | Proportion of patients with complete recanalization defined as Thrombolysis in Myocardial Infarction (TIMI) Grade 2 or 3. | Day of intervention | No |
Secondary | Complication rate | Periprocedural complication rate defined as a combination of symptomatic intracranial hemorrhage (ECASS classification PH I and PH II), subarachnoid hemorrhage and thrombembolic events. | within 36 h after endovascular procedure | Yes |
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