Acute Ischemic Stroke Due to Intracranial Large Artery Occlusion
Conditions
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
Interventions
DEVICEThrombectomy 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.
Sponsors
Yonsei University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactByung Moon Kim, PhD
Outcome results
None listed