A Clinical Trial to Assess the Acute Safety and Functional Outcome and Recovery After STROKE: The FIRST Trial

NCT ID: NCT01092819

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-12-31

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

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

acute ischemic stroke

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Penumbra Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siu Po Sit, PhD

Role: STUDY_DIRECTOR

Penumbra Inc.

Locations

Texas Stroke Institute

Plano, Texas, United States

Queen Mary Hospital

Hong Kong, Hong Kong, China

The Prince of Wales Hospital

Shatin, Hong Kong, China

Countries

United States; China

Other Identifiers

CLP 2988.B

Identifier Type: -

Identifier Source: org_study_id