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

March 13, 2020 updated by: Yonsei University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Byung Moon Kim, PhD
  • Phone Number: 82-2-2228-2399
  • Email: bmoon21@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seongdu, Korea, Republic of
        • Recruiting
        • Severance Hospital Stroke Center, Yonsei University College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with acute stroke due to ELVO within 24 hours after last seen well

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rescue stenting group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First Pass Recanalization (FPR) rate
Time Frame: Within 1 day after the completion of endovascular thrombectomyh
The rate of FPR defined by modified TICI 2b or 3
Within 1 day after the completion of endovascular thrombectomyh

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of modified Rankin scale 0-2 at 3 months after treatment
Time Frame: 90 days ± 14 days
The rate of modified Rankin Scale score (mRS), 0-2 at 90 days ± 14 days
90 days ± 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2020

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

March 13, 2020

First Submitted That Met QC Criteria

March 13, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 13, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2019-1057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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