First-pass Recanalization With EmboTrap II in Acute Ischemic Stroke (FREE-AIS)

• Conditions: Acute Ischemic Stroke Due to Intracranial Large Artery Occlusion
• Interventions: Device: Thrombectomy using EmboTrap II

• Registration Number: NCT04310306
• Lead Sponsor: Yonsei University

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 the rate of First Pass Recanalization (FPR). Patients with ELVO will initially underwent mechanical thrombectomy usig EmboTrap II. FPR is defined as modified Tissue Thrombolysis In Cerebral Ischemia (mTICI) 2b or 3

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-10
• Status Verified: 2020-03
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-13
• Last Update Submitted: 2020-03-13
• Study First Posted: 2020-03-17
• Last Update Posted: 2020-03-17
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

1. 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
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

1. Multiple simultaneous large vessel occlusions
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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rescue stenting group	Thrombectomy using EmboTrap II	-

Primary Outcome Measures

Name	Time	Method
First Pass Recanalization (FPR) rate	Within 1 day after the completion of endovascular thrombectomyh	The rate of FPR defined by modified TICI 2b or 3

Secondary Outcome Measures

Name	Time	Method
The rate of modified Rankin scale 0-2 at 3 months after treatment	90 days ± 14 days	The rate of modified Rankin Scale score (mRS), 0-2 at 90 days ± 14 days

Trial Locations

Locations (1)

Severance Hospital Stroke Center, Yonsei University College of Medicine; 🇰🇷 Seongdu, Korea, Republic of