Acute Ischemic Stroke Due to Intracranial Large Artery OcclusionNCT04310306
First-pass Recanalization With EmboTrap II in Acute Ischemic Stroke (FREE-AIS)
An observational study of Acute Ischemic Stroke Due to Intracranial Large Artery Occlusion, run by Yonsei University at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Ischemic Stroke Due to Intracranial Large Artery Occlusion
- What is being tested?
- Thrombectomy using EmboTrap II
- Type of treatment
- Medical device
- How many people
- 310 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Feb 2020to 30 Dec 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute stroke due to ELVO within 24 hours after last seen well
Who may be able to join
- 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
- Age 19 or greater
- mRS before qualifying stroke, 0 to 2
- Baseline NIHSS score 4 or more
- CT ASPECTS > 5 or MR ASPECTS > 4
- 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.
Show all 10Show fewer
- Onset (last-seen-well) time to femoral puncture time < 24 hours
- Anticipated life expectancy of at least 12 months
- Patients who undergo endovascular thrombectomy with EmboTrap II as the first-line device
- Signed informed consent for study enrollment
Who cannot join
- Multiple simultaneous large vessel occlusions
- Pregnancy
- Severe contrast allergy or absolute contraindication to iodinated contrast agent
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital Stroke Center, Yonsei University College of Medicine
Seongdu
Byung Moon Kim, PhD, 82-2-2228-2399, bmoon21@yuhs.ac
About this study
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
- Being tested
- Thrombectomy using EmboTrap II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombectomy using EmboTrap IIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Rescue stenting group | Not described Receives: Device: Thrombectomy using EmboTrap II |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Pass Recanalization (FPR) rate
The rate of FPR defined by modified TICI 2b or 3
Measured: Within 1 day after the completion of endovascular thrombectomyh
Secondary outcomes (1)
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
Measured: 90 days ± 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start10 Feb 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke Due to Intracranial Large Artery OcclusionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 310 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310306
- Sponsor's protocol ID
- 4-2019-1057
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-pass Recanalization With EmboTrap II in Acute Ischemic Stroke (FREE-AIS)
- ClinicalTrials.gov ID
- NCT04310306
- Acronym / sponsor ID
- 4-2019-1057
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rescue stenting group | – | Device: Thrombectomy using EmboTrap II |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute stroke due to ELVO within 24 hours after last seen well
Key inclusion criteria (10 listed)
- 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
- Age 19 or greater
- mRS before qualifying stroke, 0 to 2
- Baseline NIHSS score 4 or more
- CT ASPECTS > 5 or MR ASPECTS > 4
Key exclusion criteria (4 listed)
- Multiple simultaneous large vessel occlusions
- Pregnancy
- Severe contrast allergy or absolute contraindication to iodinated contrast agent
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrombectomy using EmboTrap IIThe 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. | Device | Rescue stenting group |
Primary outcome
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
1 secondary outcome
The rate of modified Rankin scale 0-2 at 3 months after treatment
Time frame: 90 days ± 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Ischemic Stroke Due to Intracranial Large Artery Occlusion
RecruitingObservational study
BASIS Technique for Endovascular Therapy of Acute Large Vessel Occlusion Strokes Due to Intracranial Atherosclerotic Disease
Acute Ischemic Stroke, ICAS - Intracranial Atherosclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke Due to Intracranial Large Artery Occlusion, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Byung Moon Kim, PhD (82-2-2228-2399, bmoon21@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Pass Recanalization (FPR) rate (time frame: Within 1 day after the completion of endovascular thrombectomyh). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.