Status:
UNKNOWN
First-pass Recanalization With EmboTrap II in Acute Ischemic Stroke (FREE-AIS)
Lead Sponsor:
Yonsei University
Conditions:
Acute Ischemic Stroke Due to Intracranial Large Artery Occlusion
Eligibility:
All Genders
19+ years
Brief Summary
This study is a prospective, open-label, multi-center, registry study, designed to to documents that EmboTrap II usage as a thrombectomy device for emergency large vessel occlusion (ELVO) in terms of ...
Eligibility Criteria
Inclusion
- Subjects experiencing acute ischemic stroke due to large vessel occlusion (intracranial internal carotid artery and middle cerebral artery M1 or proximal M2 segment, intracranial vertebral artery and basilar artery
- Age 19 or greater
- mRS before qualifying stroke, 0 to 2
- Baseline NIHSS score 4 or more
- CT ASPECTS \> 5 or MR ASPECTS \> 4
- Good collateral statues on CT angiogram (collateral grade by Calgary group, 4 or 5) or corresponding to DEFUSE 3 or DAWN trial on perfusion imaging.
- Onset (last-seen-well) time to femoral puncture time \< 24 hours
- Anticipated life expectancy of at least 12 months
- Patients who undergo endovascular thrombectomy with EmboTrap II as the first-line device
- Signed informed consent for study enrollment
Exclusion
- Multiple simultaneous large vessel occlusions
- Pregnancy
- Severe contrast allergy or absolute contraindication to iodinated contrast agent
- Patient has a severe or fatal combined illness that will prevent improvement of follow-up or will render the procedure unlikely to benefit the patient.
Key Trial Info
Start Date :
February 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT04310306
Start Date
February 10 2020
End Date
December 30 2021
Last Update
March 17 2020
Active Locations (1)
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1
Severance Hospital Stroke Center, Yonsei University College of Medicine
Seongdu, South Korea