A Study of Survival and Outcome After Stroke (SOS)
This study is currently recruiting participants.
Verified February 2014 by Penumbra Inc.
Information provided by (Responsible Party):
Siu Po Sit, Penumbra Inc.
First received: August 31, 2010
Last updated: February 19, 2014
Last verified: February 2014
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 volume who presents within 8 hours from symptom onset with a NIH Stroke Scale (NIHSS) score >10 who are eligible for mechanical thrombectomy but without receiving the treatment. Functional outcome as defined by the modified Rankin Scale (mRS) of all enrolled patients will be followed for 90 days after the index event.
||Observational Model: Cohort
Time Perspective: Prospective
||The SOS Study: A Study of Survival and Outcome After Stroke
Primary Outcome Measures:
- Proportion of patients with a modified Rankin score of 2 or less [ Time Frame: 90 days after the procedure ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- NIHSS score of 0-1 or a 10 or more points improvement [ Time Frame: Discharge ] [ Designated as safety issue: No ]
- All cause mortality [ Time Frame: 90 days post-procedure ] [ Designated as safety issue: Yes ]
- Incidents of symptomatic and asymptomatic intracranial hemorrhage [ Time Frame: 90 days post-procedure ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2014 (Final data collection date for primary outcome measure)
Standard of Care
Standard of Care for stroke except mechanical therapy
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 known infarct volume who presents within 8 hours from symptom onset with a NIH Stroke Scale (NIHSS) score >10. Functional outcome as defined by the modified Rankin Scale (mRS) of all enrolled patients will be followed for 90 days after the index event. This is a prospective, single arm, multi-center trial. Up to 200 patients at up to 30 centers will be enrolled in the study. It is anticipated that up to 150 evaluable patients will be needed for analysis. The sample size estimate is based on the primary study functional outcome at 90 days as defined by a mRS of 0-2. Assuming that this observational study will have as outcome of 25% (37/150) mRS 0-2 at day 90, the expected two-sided exact binomial confidence interval is (18%, 32%). This sample size is adequate to estimate the mRS outcome of 0-2 at day 90 for the natural history of acute ischemic stroke.
|Ages Eligible for Study:
||18 Years to 85 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients presenting with symptoms of acute ischemic stroke within 8 hours from symptom onset and with an imaging-defined large cerebral vessel occlusion and a known infarct volume will be enrolled and followed for 90-days.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193569
|Acute Vascular Imaging Centre, John Radcliffe Hospital, University of Oxford
|Oxford, United Kingdom, OX3 9DU |
|Contact: Iris Q Grunwald, MD PhD 0044 1865 234688 I.firstname.lastname@example.org |
|Principal Investigator: Iris Q Grunwald, MD PhD |
Siu Po Sit
||Iris Q Grunwald, MD
||The John Radcliffe Hospital, Oxford, UK
No publications provided
||Siu Po Sit, VP, Clinical Affairs, Penumbra Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 31, 2010
||February 19, 2014
||Oxford Radcliffe Hospitals National Health Service Trust:United Kingdom
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 09, 2014
Central Nervous System Diseases
Nervous System Diseases