Status:
COMPLETED
SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Stryker Neurovascular
Conditions:
Stroke
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
Objectives: This study aims to estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to General Anesthesia (GA) compared with Sedatio...
Eligibility Criteria
Inclusion
- Acute ischemic stroke due to large intracranial vessel occlusion demonstrated on CT-angiography in the following anterior circulation locations that will be treated by endovascular therapy (EVT):
- Internal Carotid Artery (terminal "T" or "L-type"- occlusion)
- Middle Cerebral Artery (MCA) M1 or proximal M2
- Anterior Cerebral Artery (ACA) A1 or proximal A2
- Patients who receive IV-tPA thrombolysis are eligible provided the drug was delivered within 4.5 hours of stroke onset or last seen normal and in accordance with local hospital standard of care.
- Ages 18-90.
- National Institute of Health Stroke Scale (NIHSS) score 6-30
- Time of from stroke symptom onset of last seen normal to start of EVT (defined as groin puncture) ≤ 16 hours.
- Limited infarct core, as defined below and adapted from the 2018 American Heart Association guidelines
- For patients presenting ≤ 6 hours from time of symptom onset or last seen normal, Alberta Stroke Program Early Computed Tomography Score (ASPECTS) ≥ 6
- For patients presenting \> 6 hours and ≤ 16 hours from time of symptom onset or last seen normal, they must satisfy EITHER ONE of the two following criteria:
- i. Ischemic core by CT Perfusion or MRI/MR Perfusion \< 70 mL, a ratio of volume of penumbral tissue to infarct core of ≥ 1.8, and and absolute volume of penumbral tissue of ≥ 15 mL OR ii. For patients with NIHSS ≥ 10, infarct core of \< 31 mL by CT Perfusion or MRI; For patients with NIHSS ≥ 20, infarct core \< 51 mL.
- Subject willing/able to return for protocol required follow up visits.
- No significant pre-stroke disability (modified Rankin Score must be ≤ 2).
- Females of childbearing potential must have a negative serum or urine pregnancy test.
- Patient or patient's legally authorized representative has given Informed Consent according to Good Clinical Practices (GCP) and/or local IRB policies.
Exclusion
- Coma on admission (Glasgow Coma Scale \<8), need for intubation upon ED arrival, or transferred patients who present previously intubated.
- Severe agitation or seizures on admission that preclude safe vascular access.
- Loss of airway protective reflexes and/or vomiting on admission.
- Predicted or known difficult airway.
- Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia.
- Presumed septic embolus, or suspicion of bacterial endocarditis
- Currently participating or has participated in any investigational drug or device study within 30 days.
- Inability to follow-up for 90-day assessment.
- Known history of allergy to anesthesia drugs.
- Known history or family history of malignant hyperthermia
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2023
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT03263117
Start Date
July 1 2018
End Date
April 22 2023
Last Update
November 26 2025
Active Locations (11)
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1
Indiana University College of Medicine
Indianapolis, Indiana, United States, 46202
2
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
3
Henry Ford Health System
Louisville, Kentucky, United States, 48150
4
Rochester Regional Health
Rochester, New York, United States, 14617