Status:
COMPLETED
A Study of Survival and Outcome After Stroke
Lead Sponsor:
Penumbra Inc.
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-85 years
Brief Summary
The objective of this study is to determine the natural history of acute ischemic stroke from large vessel thromboembolism in the brain. The target population is a stroke cohort with a known infarct v...
Detailed Description
The objective of this observational study is to determine the natural history of acute ischemic stroke from large vessel thromboembolism in the brain. The target population is a stroke cohort with a k...
Eligibility Criteria
Inclusion
- From 18 to 85 years of age
- Evidence of proximal anterior circulation large vessel occlusion (TIMI 0-1/TICI 0-1)from CT Angiography. Target vessel occlusion may include the supra-clinoid segment of the ICA through the M1 segment of the MCA.
- Presented with symptoms consistent with acute ischemic stroke within 8 hours of symptom onset. Patients who presented within 3 hours must be ineligible or refractory to IV rtPA therapy.
- At time of enrollment, neurological deficit resulting in an NIH Stroke Scale (NIHSS) score \> 10
- Known core infarct volume assessed by CTP, CTA or DWI scans
Exclusion
- History of stroke in the past 3 months.
- Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score \>1
- Known severe allergy to contrast media
- Uncontrolled hypertension (defined as systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg)
- CT evidence of the following conditions before enrollment:
- Significant mass effect with midline shift
- Evidence of intracranial hemorrhage
- Treated with endovascular therapy for acute stroke
- Life expectancy was thought to be less than 90 days prior to stroke due to non-stroke illness
- Participation in another clinical investigation that could confound the evaluation of the study
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 22 2016
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT01193569
Start Date
September 1 2010
End Date
December 22 2016
Last Update
April 12 2018
Active Locations (1)
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1
Acute Vascular Imaging Centre, John Radcliffe Hospital, University of Oxford
Oxford, United Kingdom, OX3 9DU