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

Yonsei University

Status: Unknown

Conditions: Acute Ischemic Stroke Due to Intracranial Large Artery Occlusion

Treatments: Device: Thrombectomy using EmboTrap II

Study type: Observational

Funder types: Other

Identifiers

NCT04310306

4-2019-1057

Details and patient eligibility

About

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

Enrollment: 310 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

310 participants in 1 patient group

Rescue stenting group

Treatment:

Device: Thrombectomy using EmboTrap II