Status:
TERMINATED
Collateral-based reSetting of Endovascular Treatment Time Window for Stroke (CoSETS)
Lead Sponsor:
Yonsei University
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
This study is a prospective, partly randomized, multi-center, Phase III, controlled trial, designed to show that the onset-to-puncture time (OPT) for good functional outcome (defined by modified Ranki...
Eligibility Criteria
Inclusion
- Acute ischemic stroke
- Age ≥ 19 years old
- Modified Rankin Scale score before qualifying stroke, 0 or 1
- Baseline National Institute of Health Stroke Scale, 5 or greater
- Baseline Alberta Stroke Program Early Computed Tomographic Sign, 6 or greater
- Documented occlusion of relevant intracranial internal carotid artery or middle cerebral artery M1 segment on multiphase CT angiogram
- Starting of endovascular treatment (femoral artery puncture) should be possible between 150 minutes and 600 minutes after last seen well time.
- Nonenhanced CT and multiphase CT angiogram should be obtained in the participating hospital
- If indicated, intravenous administration of tissue plasminogen activator should be given.
Exclusion
- Femoral puncture is impossible
- Pregnancy or positive on serum beta-hCG test
- Known uncontrollable allergic reaction to iodized contrast media
- Intracranial cerebral artery dissection
- Suspected chronic occlusion of the relevant intracranial large artery
- In hospital stroke
- Bilateral internal carotid artery or middle cerebral artery occlusion
- Underlying severe medical or surgical disease which may affect treatment response.
- Clinical follow is impossible because of social or medical problems.
Key Trial Info
Start Date :
August 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2019
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT03234634
Start Date
August 13 2018
End Date
May 20 2019
Last Update
June 21 2019
Active Locations (1)
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1
Yonsei University Healthcare System, Severance Hospital
Seoul, Yeonsei-ro Seodaemun-gu, South Korea, 03722