First-pass Recanalization With EmboTrap II in Acute Ischemic Stroke (FREE-AIS)
NCT ID: NCT04310306
Last Updated: 2020-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
310 participants
OBSERVATIONAL
2020-02-10
2021-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rescue stenting group
Thrombectomy using EmboTrap II
The subjects will receive endovascular treatment for acute stroke according to standard clinical practice. Specifically, using a stent retriever, contact aspiration EmboTrap II. The number of thrombectomy attempts is at the operator's discretion. Combination of balloon guide catheter or intermediate catheter is recommended.
Interventions
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Thrombectomy using EmboTrap II
The subjects will receive endovascular treatment for acute stroke according to standard clinical practice. Specifically, using a stent retriever, contact aspiration EmboTrap II. The number of thrombectomy attempts is at the operator's discretion. Combination of balloon guide catheter or intermediate catheter is recommended.
Eligibility Criteria
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Inclusion Criteria
2. Age 19 or greater
3. mRS before qualifying stroke, 0 to 2
4. Baseline NIHSS score 4 or more
5. CT ASPECTS \> 5 or MR ASPECTS \> 4
6. 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.
7. Onset (last-seen-well) time to femoral puncture time \< 24 hours
8. Anticipated life expectancy of at least 12 months
9. Patients who undergo endovascular thrombectomy with EmboTrap II as the first-line device
10. Signed informed consent for study enrollment
Exclusion Criteria
2. Pregnancy
3. Severe contrast allergy or absolute contraindication to iodinated contrast agent
4. 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.
19 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Severance Hospital Stroke Center, Yonsei University College of Medicine
Seongdu, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-2019-1057
Identifier Type: -
Identifier Source: org_study_id
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