Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04310306
  4. Details
NCT04310306 Clinical Trial

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

Acute Ischemic Stroke Due to Intracranial Large Artery Occlusion Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04310306
Other study ID # 4-2019-1057
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 10, 2020
Est. completion date December 30, 2021

Study information
Verified date March 2020
Source Yonsei University
Contact Byung Moon Kim, PhD
Phone 82-2-2228-2399
Email bmoon21@yuhs.ac
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 310
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• 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.

Locations
Country Name City State
Korea, Republic of Severance Hospital Stroke Center, Yonsei University College of Medicine Seongdu

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary First Pass Recanalization (FPR) rate The rate of FPR defined by modified TICI 2b or 3 Within 1 day after the completion of endovascular thrombectomyh
Secondary The rate of modified Rankin scale 0-2 at 3 months after treatment The rate of modified Rankin Scale score (mRS), 0-2 at 90 days ± 14 days 90 days ± 14 days