Overview

This trial is active, not recruiting.

Condition stroke
Treatment current standard of care for acute ischemic stroke other than iv rtpa or other ia therapies
Sponsor Penumbra Inc.
Start date December 2012
End date June 2016
Trial size 150 participants
Trial identifier NCT01092819, CLP 2988.B

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients presenting with symptoms of acute ischemic stroke within 8 hours from symptom onset and with an imaging-defined large cerebral vessel occlusion.
current 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.

Primary Outcomes

Measure
Functional outcome at 90 days after presentation as defined by a modified Rankin Score of 0-2.
time frame: 90 days after presentation

Secondary Outcomes

Measure
• 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.
time frame: Discharge and 90 days after presentation
All cause mortality
time frame: Dishcharge and 90 days after presentation
Incidence of symptomatic and asymptomatic hemorrhage
time frame: Dishcharge and 90 days after presentation

Eligibility Criteria

Male participants from 18 years up to 85 years old.

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

Additional Information

Official title Functional Outcome and Recovery After STROKE: The FIRST Trial
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Penumbra Inc..