A Study of Survival and Outcome After Stroke (SOS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Penumbra Inc.
Sponsor:
Information provided by (Responsible Party):
Siu Po Sit, Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT01193569
First received: August 31, 2010
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Phase
Ischemic Stroke
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The SOS Study: A Study of Survival and Outcome After Stroke

Resource links provided by NLM:


Further study details as provided by Penumbra Inc.:

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: 150
Study Start Date: September 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Standard of Care
Standard of Care for stroke except mechanical therapy

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193569

Contacts
Contact: Iris Q Grunwald, MD, PhD 0044 1865 234688 I.grunwald@gmx.net

Locations
United Kingdom
Acute Vascular Imaging Centre, John Radcliffe Hospital, University of Oxford Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Iris Q Grunwald, MD PhD    0044 1865 234688    I.grunwald@gmx.net   
Principal Investigator: Iris Q Grunwald, MD PhD         
Sponsors and Collaborators
Siu Po Sit
Investigators
Principal Investigator: Iris Q Grunwald, MD The John Radcliffe Hospital, Oxford, UK
  More Information

No publications provided

Responsible Party: Siu Po Sit, VP, Clinical Affairs, Penumbra Inc.
ClinicalTrials.gov Identifier: NCT01193569     History of Changes
Other Study ID Numbers: CLP2818, CLP2818
Study First Received: August 31, 2010
Last Updated: February 19, 2014
Health Authority: Oxford Radcliffe Hospitals National Health Service Trust:United Kingdom

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 21, 2014