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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03234634
Recruitment Status : Terminated (As the guideline for the acute stroke endovascular treatment of the AHA/ASA was changed, DSMB recommended an end to the study.)
First Posted : July 31, 2017
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Procedure: endovascular thrombectomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention 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 (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Collateral-based reSetting of Endovascular Treatment Time Window for Stroke (CoSETS)
Actual Study Start Date : August 13, 2018
Actual Primary Completion Date : May 20, 2019
Actual Study Completion Date : May 20, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Group 1: patients with good collateral
Experimental: Group 2a, patient with poor collaterals
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.
 Procedure: endovascular thrombectomy

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.
Other Name: best medical treatment
No Intervention: Group 2b, patients with poor collaterals
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.


Outcome Measures
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Primary Outcome Measures :
  1. The rate of good functional outcome defined by modified Rankin Scale score 0 - 2 [ Time Frame: 90 days ± 14 days after enrollment ]

    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.


Secondary Outcome Measures :
  1. modified Rankin Scale score [ Time Frame: 90 days ± 14 days after enrollment ]
  2. NIHSS score [ Time Frame: 24 hours after enrollment ]
  3. NIHSS score [ Time Frame: 72 hours after enrollment ]
  4. NIHSS score [ Time Frame: 7 days after enrollment ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234634


Locations
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Korea, Republic of
Yonsei University Healthcare System, Severance Hospital
Seoul, Yeonsei-ro Seodaemun-gu, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03234634    
Other Study ID Numbers: 4-2017-0511
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases