Ischemic Stroke Clinical Trial
— SOSOfficial title:
The SOS Study: A Study of Survival and Outcome After Stroke
Verified date | April 2018 |
Source | Penumbra Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 142 |
Est. completion date | December 22, 2016 |
Est. primary completion date | December 22, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Acute Vascular Imaging Centre, John Radcliffe Hospital, University of Oxford | Oxford |
Lead Sponsor | Collaborator |
---|---|
Penumbra Inc. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with a modified Rankin score of 2 or less | 90 days after the procedure | ||
Secondary | NIHSS score of 0-1 or a 10 or more points improvement | Discharge | ||
Secondary | All cause mortality | 90 days post-procedure | ||
Secondary | Incidents of symptomatic and asymptomatic intracranial hemorrhage | 90 days post-procedure |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Recruiting |
NCT05518305 -
Platelet Expression of FcγRIIa and Arterial Hemodynamics to Predict Recurrent Stroke in Intracranial Atherosclerosis
|
||
Recruiting |
NCT06029959 -
Stroke and CPAP Outcome Study 3
|
N/A | |
Recruiting |
NCT03728738 -
Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke
|
Phase 3 | |
Terminated |
NCT03396419 -
IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
|
||
Recruiting |
NCT05065216 -
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
|
Phase 2/Phase 3 | |
Recruiting |
NCT04897334 -
Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke
|
N/A | |
Not yet recruiting |
NCT06026696 -
Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
|
||
Not yet recruiting |
NCT06032819 -
Differentiating Between Brain Hemorrhage and Contrast
|
||
Recruiting |
NCT02910180 -
Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
|
||
Completed |
NCT02922452 -
A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects
|
Phase 1 | |
Completed |
NCT03554642 -
Walkbot Robotic Training for Improvement in Gait
|
Phase 3 | |
Withdrawn |
NCT01866189 -
Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke
|
N/A | |
Recruiting |
NCT03041753 -
Reperfusion Injury After Stroke Study
|
N/A | |
Completed |
NCT02549846 -
AdminiStration of Statin On Acute Ischemic stRoke patienT Trial
|
Phase 4 | |
Completed |
NCT01678534 -
Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial
|
Phase 2 | |
Completed |
NCT02610803 -
Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke
|
N/A | |
Terminated |
NCT01852201 -
POSITIVE Stroke Clinical Trial
|
N/A |