A Clinical Trial to Assess the Acute Safety and Functional Outcome and Recovery After STROKE: The FIRST Trial
Completed
Conditions studied: Stroke
In brief
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
Key facts
- Study ID
- NCT01092819
- Run by
- Penumbra Inc.
- People needed
- 150
- Starts
- 2012-12-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2019-04-12
Who can join
Age: 18 and older, up to 85. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Texas Stroke Institute — Plano, Texas, United States
- Queen Mary Hospital — Hong Kong, Hong Kong, China
- The Prince of Wales Hospital — Shatin, Hong Kong, China
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.