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Acute Ischemic StrokeNCT03234634

Collateral-based reSetting of Endovascular Treatment Time Window for Stroke (CoSETS)

A study testing endovascular thrombectomy in people with Acute Ischemic Stroke, run by Yonsei University at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is a prospective, partly randomized, multi-center, Phase III, controlled trial, designed to show that the onset-to-puncture time (OPT) for good functional outcome (defined by modified Rankin Scale score at 3 months, 0-2) can be set depending on collateral status based on multiphase CT angiogram. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
endovascular thrombectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
291 participants
Where
1 siteSouth Korea
Study dates
13 Aug 2018to 20 May 2019
Phase
Interventional
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

Who may be able to join

  • Acute ischemic stroke
  • Age ≥ 19 years old
  • Modified Rankin Scale score before qualifying stroke, 0 or 1
  • Baseline National Institute of Health Stroke Scale, 5 or greater
  • Baseline Alberta Stroke Program Early Computed Tomographic Sign, 6 or greater
  • Documented occlusion of relevant intracranial internal carotid artery or middle cerebral artery M1 segment on multiphase CT angiogram
Show all 9Show fewer
  • Starting of endovascular treatment (femoral artery puncture) should be possible between 150 minutes and 600 minutes after last seen well time.
  • Nonenhanced CT and multiphase CT angiogram should be obtained in the participating hospital
  • If indicated, intravenous administration of tissue plasminogen activator should be given.

Who cannot join

  • Femoral puncture is impossible
  • Pregnancy or positive on serum beta-hCG test
  • Known uncontrollable allergic reaction to iodized contrast media
  • Intracranial cerebral artery dissection
  • Suspected chronic occlusion of the relevant intracranial large artery
  • In hospital stroke
Show all 9Show fewer
  • Bilateral internal carotid artery or middle cerebral artery occlusion
  • Underlying severe medical or surgical disease which may affect treatment response.
  • Clinical follow is impossible because of social or medical problems.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yonsei University Healthcare System, Severance Hospital

    Seoul, Yeonsei-ro Seodaemun-gu, 03722

Other trials in South Korea

About this study

This study is a prospective, partly randomized, multi-center, Phase III, controlled trial, designed to show that the onset-to-puncture time (OPT) for good functional outcome (defined by modified Rankin Scale score at 3 months, 0-2) can be set depending on collateral status based on multiphase CT angiogram. The purpose of this study is to prove that (1) for patients with poor collaterals, there will no difference in good outcome rate between endovascular treatment and best medical treatment group if onset-to-puncture time is between 150 minutes and 600 minutes, and 2) for patients wih good collaterals, the rate of good outcome is equal to or greater than 42% (10% greater than historical control) if onset-to-puncture time is between 150 minutes and 600 minutes. Patients will initially be classified into 3 arms based on both collateral status on multiphase CT angiography and whether or not receiving endovascular thrombectomy: group 1, patients with good collaterals and receiving endovascular thrombectomy, 2) group 2a, patient with poor collaterals and receiving endovascular thrombectomy, and 3) group 2b, patients with poor collaterals and not receiving endovascular thrombectomy. Patients with good collaterals will receive endovascular thrombectomy (EVT) if onset-to-puncture time is between 150 minutes and 600 minutes after last seen well time. Of the patients with poor collaterals, they will be randomized into endovascular treatment and best medical treatment group, if onset-to-puncture time is between 150 minutes and 600 minutes, (onset-to-puncture time is not possible within 150 minutes but possible within 600 minutes after last seen well). Primary endpoint is the rate of good outcome at 3 months. The number of subjects needed with statistical power of 0.8 and alpha value of 0.025 is estimated 309 patients.

Being tested
endovascular thrombectomy
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endovascular thrombectomyProcedure or surgery

    Also called best medical treatment

    Intervention description : Group 1: patients with good collateral, Group 2: patient with poor collateral

    1. Group 1 patients (good collateral group) will receive endovascular thrombectomy using stent retriever, aspiration catheter, or both, if femoral puncture is possible between 150 minutes and 600 minutes after last seen well.
    2. Group 2 patients (poor collateral group) will be randomized into endovascular thrombectomy group (2a) and best medical treatment group (2b), if femoral puncture is possible between 150 minutes and 600 minutes after last seen well.
Study groups in NCT03234634
Study groupRoleWhat they receive
Group 1: patients with good collateralNo interventionNot described
Group 2a, patient with poor collateralsExperimentalGroup 2 patients (poor collateral group) will be randomized into endovascular thrombectomy group (2a) and best medical treatment group (2b), if femoral puncture is possible between 150 minutes and 600 minutes after last seen well.
Receives: Procedure: endovascular thrombectomy
Group 2b, patients with poor collateralsNo interventionGroup 2 patients (poor collateral group) will be randomized into endovascular thrombectomy group (2a) and best medical treatment group (2b), if femoral puncture is possible between 150 minutes and 600 minutes after last seen well.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of good functional outcome defined by modified Rankin Scale score 0 - 2

    The scale runs from 0-6, running from perfect health without symptoms to death 0 - No symptoms.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead.

    Measured: 90 days ± 14 days after enrollment

Secondary outcomes (4)

  1. modified Rankin Scale score

    Measured: 90 days ± 14 days after enrollment

  2. NIHSS score

    Measured: 24 hours after enrollment

  3. NIHSS score

    Measured: 72 hours after enrollment

  4. NIHSS score

    Measured: 7 days after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2017
  2. Study start13 Aug 2018
  3. Primary completion20 May 2019
  4. Study completion20 May 2019

Why it stopped: As the guideline for the acute stroke endovascular treatment of the AHA/ASA was changed, DSMB recommended an end to the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
Patients will be dichotomized into good collateral (group 1) and poor collateral group (group 2) according to collateral status assessed on multiphase CT angiography.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
291 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03234634
Sponsor's protocol ID
4-2017-0511
Status last verified
Jun 2019
First submitted
26 Jul 2017
Last updated
21 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yu I, Bang OY, Chung JW, Kim YC, Choi EH, Seo WK, Kim GM, Menon BK, Demchuk AM, Goyal M, Hill MD. Admission Diffusion-Weighted Imaging Lesion Volume in Patients With Large Vessel Occlusion Stroke and Alberta Stroke Program Early CT Score of >/=6 Points: Serial Computed Tomography-Magnetic Resonance Imaging Collateral Measurements. Stroke. 2019 Nov;50(11):3115-3120. doi: 10.1161/STROKEAHA.119.026229. Epub 2019 Sep 26.

    PubMed 31554502

Questions about this trial

What is this clinical trial studying?

A study testing endovascular thrombectomy in people with Acute Ischemic Stroke, 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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 21 Jun 2019. 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?

The study was stopped early (reason given: As the guideline for the acute stroke endovascular treatment of the AHA/ASA was changed, DSMB recommended an end to the study.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of good functional outcome defined by modified Rankin Scale score 0 - 2 (time frame: 90 days ± 14 days after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03234634, which also lists 1 linked publication.

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 21 Jun 2019.

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