Stroke
Conditions
Keywords
acute ischemic stroke, large vessel occlusion, natural history, functional outcome
Brief summary
Current literature has only limited information on the natural history of acute ischemic stroke from large vessel occlusion in a stroke cohort who presents within 8 hours from symptom onset, particularly on 90 day functional outcome as defined by the mRS. Data from this trial will advance our knowledge on this important topic and may serve as a bench mark for future trials
Interventions
OTHERCurrent standard of care for acute ischemic stroke other than IV rtPA or other IA therapies
The objective of this study is to determine the natural history of acute ischemic stroke from large vessel thromboembolism in the brain. Patients with current standard of care other than IV rtPA or IA therapies will be studied.
Sponsors
Penumbra Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
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 anterior circulation. * 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 greater than 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 greater than 1 * Known severe allergy to contrast media * Uncontrolled hypertension (defined as systolic blood pressure greater than 185 mmHg or diastolic blood pressure less than 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 less than 90 days * Participation in another clinical investigation that could confound the evaluation of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional outcome at 90 days after presentation as defined by a modified Rankin Score of 0-2. | 90 days after presentation |
Secondary
| Measure | Time frame |
|---|---|
| • Good neurological recovery as defined by a NIHSS score of 0-1 at discharge or a 10-point or more improvement in this scale at discharge. | Discharge and 90 days after presentation |
| All cause mortality | Dishcharge and 90 days after presentation |
| Incidence of symptomatic and asymptomatic hemorrhage | Dishcharge and 90 days after presentation |
Countries
China, United States
Outcome results
None listed