Actively Recruiting
SEACOAST 1- SEdAtion With COllAteral Support in Endovascular Therapy for Acute Ischemic Stroke
Led by University of California, Los Angeles · Updated on 2025-12-26
90
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
U
University of Southern California
Collaborating Sponsor
AI-Summary
What this Trial Is About
SEACOAST 1 is a prospective, randomized, blinded endpoint trial comparing collateral vigor and clinical outcomes, with different forms of GA in patients with acute ischemic stroke due to anterior circulation large vessel occlusion (LVO) undergoing mechanical thrombectomy. The study compares GA with normocarbia (GAN) versus GA with mild hypercarbia (GAH), with a primary outcome of collateral robustness at measured at catheter angiography and clinical efficacy as secondary outcome. It is anticipated that the SEACOAST 1 will be followed by a larger, pivotal trial, SEACOAST 2, with primary clinical endpoints, in which the best method of GA identified in SEACOAST 1 is compared with the alternative strategy of anesthesia care (MAC) with minimal or no sedation. The current study focuses uppn SEACOAST 1, which is to be conducted in University of California, Los Angeles Ronald Reagan Medical Center and Santa Monica Medical Center. All acute stroke patients who arrive to one of these two stroke centers and are deemed eligible for thrombectomy will be considered for the proposed study. Physician-investigators will determine study eligibility. Informed consent to participate in the study will be obtained from legally authorized representatives or competent patients. For non-competent patients without on-scene legally authorize representatives, the consent process will utilize enrollment in emergency circumstances with exemption of informed consent (EFIC).
CONDITIONS
Official Title
SEACOAST 1- SEdAtion With COllAteral Support in Endovascular Therapy for Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- NIH Stroke Scale (NIHSS) score 6 or higher within 0-16 hours or 10 or higher within 16-24 hours
- Presence of anterior circulation large vessel occlusion (ICA, M1, M2)
- ASPECTS score 6 or higher within the first 6 hours, or meeting DEFUSE trial imaging criteria within 6-16 hours, or meeting DAWN trial clinical/imaging mismatch criteria within 16-24 hours
- Premorbid modified Rankin Scale (mRS) score between 0 and 2
- Candidate for mechanical thrombectomy with expected groin puncture within 24 hours of last known well and within 90 minutes of emergency department arrival
You will not qualify if you...
- Intubation in emergency department before anesthesiologist evaluation or for reasons other than planned thrombectomy
- Rapid neurological improvement suggesting revascularization
- Known serious allergy to radiographic contrast agents
- Current participation in another investigational drug or device study
- Renal failure with serum creatinine over 2.0 mg/dl or glomerular filtration rate below 30
- Requirement for hemodialysis or peritoneal dialysis or contraindication to angiogram
- Life expectancy less than 90 days
- Clinical signs suggesting subarachnoid hemorrhage even if initial imaging is normal
- Co-morbid disease or condition that would affect neurological or functional evaluations or follow-up
- Recent or current illicit drug use or alcohol abuse (more than 4 drinks daily)
- Septic or cardiogenic shock with severe life-threatening low blood pressure
- Imaging showing acute intracranial hemorrhage
- Imaging evidence of mass effect or intracranial tumor (except small meningioma)
- Imaging showing large area (>1/3 MCA territory or >100 cc) of brain tissue damage
- ASPECTS score below 6 indicating moderate/large ischemic core
- Imaging showing ischemia outside anterior circulation
- Investigator's opinion that thrombectomy is not appropriate due to anatomy or poor collateral circulation
- History of malignant hyperthermia
- History of allergic reaction or anaphylaxis to anesthetic drugs
- Inability to tolerate lying flat (severe congestive heart failure)
- Chronic oxygen dependence or pulmonary conditions risking difficult extubation or prolonged ventilation including pulmonary hypertension
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UCLA Stroke Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
R
Radoslav Raychev, MD
CONTACT
G
Gilda Avila
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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