AzTrials
AzTrials

Ischemic StrokeDAWNNCT02142283

Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo

A study testing Trevo Thrombectomy Procedure and Medical Management in people with Ischemic Stroke, run by Stryker Neurovascular at 32 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
Trevo Thrombectomy Procedure and Medical Management
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
32 sitesin 5 countries
Study dates
Jul 2014to 15 May 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

General Inclusion Criteria:

  1. Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups:
  2. Subject has failed IV t-PA therapy (defined as a confirmed persistent occlusion 60 min after administration)
  3. Subject is contraindicated for IV t-PA administration
  4. Age ≥18
  5. Baseline NIHSS ≥10 (assessed within one hour of measuring core infarct volume)
  6. Subject can be randomized between with 6 to 24 hours after time last known well
  7. No significant pre-stroke disability (pre-stroke mRS must be 0 or 1)
  8. Anticipated life expectancy of at least 6 months
  9. Subject willing/able to return for protocol required follow up visits
  10. Subject or subject's Legally Authorized Representative (LAR) has signed the study Informed Consent form*
  • If approved by local ethics committee and country regulations, the investigator is allowed to enroll a patient utilizing emergency informed consent procedures if neither the patient nor the representative or person of trust is available to sign the informed consent form. However, as soon as possible, the patient is informed and his/her consent is requested for the possible continuation of this research. (Not applicable to U.S. Sites.)

Imaging Inclusion Criteria:

  1. < 1/3 MCA territory involved, as evidenced by CT or MRI
  2. Occlusion of the intracranial ICA and/or MCA-M1 as evidenced by MRA or CTA
  3. Clinical Imaging Mismatch (CIM) defined as one of the following on MR-DWI or CTP-rCBF maps:
  4. 0-<21 cc core infarct and NIHSS ≥ 10 (and age ≥ 80 years old)
  5. 0-<31 cc core infarct and NIHSS ≥ 10 (and age < 80 years old)
  6. 31 cc to <51 cc core infarct and NIHSS ≥ 20 (and age < 80 years old)

General Exclusion Criteria:

  1. History of severe head injury within past 90 days with residual neurological deficit, as determined by medical history
  2. Rapid improvement in neurological status to an NIHSS <10 or evidence of vessel recanalization prior to randomization
  3. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept)
  4. Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment
  5. Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol)
  6. Baseline hemoglobin counts of <7 mmol/L
  7. Baseline platelet count < 50,000/uL
  8. Abnormal baseline electrolyte parameters as defined by sodium concentration <130 mmol/L, potassium concentration <3 mEq/L or >6 mEq/L
  9. Renal failure as defined by a serum creatinine >3.0 mg/dL (264 µmol/L) NOTE: subjects on renal dialysis may be treated regardless of serum creatinine levels
  10. Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR > 3.0 or PTT > 3 times normal. Patients on factor Xa inhibitor for 24-48 hours ago must have a normal PTT.
  11. Any active or recent hemorrhage within the past 30 days
  12. History of severe allergy (more than rash) to contrast medium
  13. Severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using medication the subject can be enrolled
  14. Female who is pregnant or lactating at time of admission
  15. Current participation in another investigational drug or device study
  16. Presumed septic embolus, or suspicion of bacterial endocarditis
  17. Treatment with any cleared thrombectomy devices or other intra-arterial (neurovascular) therapies prior to randomization

Imaging Exclusion Criteria:

  1. Evidence of intracranial hemorrhage on CT/MRI
  2. CTA or MRA evidence of flow limiting carotid dissection, high-grade stenosis, or complete cervical carotid occlusion requiring stenting at the time of the index procedure (i.e., mechanical thrombectomy).
  3. Excessive tortuosity of cervical vessels on CTA/MRA that would likely preclude device delivery/deployment
  4. Suspected cerebral vasculitis based on medical history and CTA/MRA
  5. Suspected aortic dissection based on medical history and CTA/MRA
  6. Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the Trevo device
  7. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior circulation/vertebrobasilar system) as confirmed on CTA/MRA, or clinical evidence of bilateral strokes or strokes in multiple territories
  8. Significant mass effect with midline shift as confirmed on CT/MRI
  9. Evidence of intracranial tumor (except small meningioma) as confirmed on CT/MRI

Trial locations and contacts

32 sites in 5 countries.

32 sites in 5 countries

United States24 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Emory University at Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Buffalo General Medical Center

    Buffalo, New York, 14203

  • Erlanger Health System

    Chattanooga, Tennessee, 37377

  • RUSH University Medical Center

    Chicago, Illinois, 60612

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44026

  • Riverside Methodist Hospital/ Ohio Health Research Institute

    Columbus, Ohio, 43214

  • JFK Neuroscience Institute at JFK Medical Center

    Edison, New Jersey, 08818

  • Valley Baptist Medical Center-Harlingen

    Harlingen, Texas, 78550

  • Memorial Regional

    Hollywood, Florida, 33021

  • Baptist Jacksonville

    Jacksonville, Florida, 32207

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Jackson Memorial/University of Miami

    Miami, Florida, 33136

  • Christiana Care

    Newark, Delaware, 19718

  • Florida Hospital; Neuroscience Research Center

    Orlando, Florida, 32803

  • UPMC Stroke Institute

    Pittsburgh, Pennsylvania, 15213

  • North Texas Stroke Center HCA (dba TSI)

    Plano, Texas, 75075

  • St. Joseph Mercy - Oakland

    Pontiac, Michigan, 48341

  • California Pacific Medical Center

    San Francisco, California, 94114

  • Capital Health System

    Trenton, New Jersey, 08638

Other trials in United States

Spain4 sites

  • Vall d'Hebron Barcelona

    Barcelona, 08035

  • Hospital Clinic - Barcelona

    Barcelona, 08036

  • Hospital Germans Trias I Pujol

    Barcelona, 08916

  • Hospital Universitari de Bellvitge

    Barcelona

Other trials in Spain

France2 sites

  • Hôpital Gui de Chauliac

    Montpellier, 34295

  • Hopital Purpan - Toulouse

    Toulouse, 40031

Other trials in France

Australia1 site

  • Royal Melbourne

    Parkville, 3050

Other trials in Australia

Canada1 site

  • Toronto Western Hospital - University Health Network

    Toronto, Ontario

Other trials in Canada

About this study

Official title: Diffusion Weighted Imaging (DWI) or Computerized Tomography Perfusion (CTP) Assessment With Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention (DAWN)

The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last seen well.

Read the detailed description

The study is a prospective, randomized, multi-center, Phase II/III (feasibility/pivotal), adaptive, controlled trial, designed to demonstrate that mechanical thrombectomy using the Trevo Retriever with medical management is superior to medical management alone in improving clinical outcomes at 90 days in appropriately selected wake up and late presenting acute ischemic stroke subjects.

The intent of this study is to support the use of the Trevo Retriever beyond the currently labeled 8 hour indicated time limit in wake up, unclear onset, and late presenting ischemic stroke subjects, who currently have no other option besides medical management of their symptoms.

Patients with wake-up strokes, strokes with unclear onset time, and witnessed late presenting strokes may potentially benefit from intra-arterial reperfusion therapy. However, an important indicator of whether subjects will benefit or not during this later time window is the confirmation of a large vessel occlusion (LVO), and assessment of the core infarct volume relative to the volume of salvageable penumbra. Therefore, standardized imaging selection of subjects is required for inclusion into the study.

This trial has been designed with subject safety in mind, as a seamless Phase II (feasibility) / Phase III (pivotal) adaptive design, in order to address the concerns around potential unknown harms to enrolled subjects. This study will help to answer the question of whether carefully selecting subjects by using Clinical Imaging Mismatch will allow acute ischemic stroke patients who present at or beyond 6 hours from Time Last Seen Well (TLSW) to be considered for intra-arterial intervention. If Trevo thrombectomy plus medical management leads to better clinical outcomes over medical management alone, more patients in the future could receive endovascular treatment (either in addition to or in lieu of IV tPA).

Conditions
Ischemic Stroke
Being tested
Trevo Thrombectomy Procedure, Medical Management
Keywords
Mechanical thrombectomy, Acute ischemic stroke, Wake up stroke, Late presenting stroke
Medical subject headings
Ischemic Stroke

What participants receive

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

  • Trevo Thrombectomy ProcedureDevice

    Also called Trevo ProVue Retriever, Trevo XP ProVue Retriever

    stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)

  • Medical ManagementOther

    Also called Standard of Care

    Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Study groups in NCT02142283
Study groupRoleWhat they receive
Trevo Thrombectomy ProcedureExperimentalTrevo Thrombectomy Procedure and Medical Management
Receives: Device: Trevo Thrombectomy Procedure; Other: Medical Management
Medical ManagementActive comparatorMedical Management
Receives: Other: Medical Management

What is being measured

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

  1. Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome

    mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes neurological disability.

    Functional Independence:

    0 - no symptoms at all

    1. - no significant disability despite symptoms; able to carry out all usual duties and activities
    2. - slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    3. - moderate disability; requiring some help, but able to walk without assistance
    4. - moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    5. - severe disability; bedridden, incontinent and requiring constant nursing care and attention
    6. - dead

    Measured: 90 days

  2. Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome

    Number of participants with functional independence

    mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes neurological disability.

    Functional Independence:

    0 - no symptoms at all

    1. - no significant disability despite symptoms; able to carry out all usual duties and activities
    2. - slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance

    Measured: 90 days

  3. Stroke-related Mortality, Primary Safety Outcome

    Measured: 90 days

Secondary outcomes (5)

  1. Good Functional Outcome

    Proportion of participants with functional independence

    mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes neurological disability.

    Functional Independence:

    0 - no symptoms at all

    1. - no significant disability despite symptoms; able to carry out all usual duties and activities
    2. - slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance

    Measured: 90 days

  2. Early Response

    The proportion of subjects with "early response" at Day 5-7/Discharge (whichever is earlier), defined as a National Institutes of Health Stroke Scale (NIHSS) drop of ≥10 from baseline or NIHSS score 0 or 1.

    The NIHSS is an assessment which objectively quantifies the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

    Measured: 5-7 Days

  3. All Cause Mortality

    Measured: 90 days

  4. Revascularization Rates

    Revascularization rates at 24 hours from randomization are based on the assessment of vessel patency utilizing CTA/MRA and processed by the CT-MR core laboratory. Revascularization at 24 hours was defined as the presence of partial or complete recanalization.

    CTA/MRA images utilized ionizing radiation exposure.

    Measured: 24 hours

  5. Neurological Deterioration From Baseline NIHSS Score

    Neurological deterioration from baseline NIHSS score through Day 5-7/discharge (whichever is earlier) post randomization. Neurological deterioration is defined as ≥ 4 point increase in the NIHSS score from the baseline score.

    The calculated difference in NIHSS scores was assessed at baseline and Day 5-7/discharge (two time points).

    The NIHSS is an assessment which objectively quantifies the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

    Measured: 5-7 days

Timeline

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

  1. First posted20 May 2014 (estimated)
  2. Study startJul 2014
  3. Primary completion15 May 2017
  4. Study completion15 May 2017

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
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02142283
Sponsor's protocol ID
T4024
Acronym
DAWN
Status last verified
Jul 2018
First submitted
15 May 2014
Last updated
20 Jul 2018
Data monitoring committee
Yes

Publications

  • Roaldsen MB, Lindekleiv H, Mathiesen EB. Intravenous thrombolytic treatment and endovascular thrombectomy for ischaemic wake-up stroke. Cochrane Database Syst Rev. 2021 Dec 1;12(12):CD010995. doi: 10.1002/14651858.CD010995.pub3.

    PubMed 34850380

  • Liebeskind DS, Saber H, Xiang B, Jadhav AP, Jovin TG, Haussen DC, Budzik RF, Bonafe A, Bhuva P, Yavagal DR, Hanel RA, Ribo M, Cognard C, Sila C, Hassan AE, Smith WS, Saver JL, Nogueira RG; DAWN Investigators. Collateral Circulation in Thrombectomy for Stroke After 6 to 24 Hours in the DAWN Trial. Stroke. 2022 Mar;53(3):742-748. doi: 10.1161/STROKEAHA.121.034471. Epub 2021 Nov 3.

    PubMed 34727737

  • Liebeskind DS, Saber H, Bhuva P, Xiang B, Yoo AJ, Jadhav AP, Haussen DC, Budzik RF, Bonafe A, Yavagal DR, Hanel RA, Ribo M, Cognard C, Sila C, Hassan AE, Smith WS, Saver JL, Nogueira RG, Jovin TG. Serial ASPECTS in the DAWN Trial: Infarct Evolution and Clinical Impact. Stroke. 2021 Oct;52(10):3318-3324. doi: 10.1161/STROKEAHA.120.033477. Epub 2021 Jul 20.

    PubMed 34281376

  • Tekle WG, Hassan AE, Jadhav AP, Haussen DC, Budzik RF, Bonafe A, Bhuva P, Yavagal DR, Hanel RA, Ribo M, Cognard C, Sila CA, Smith WS, Saver JL, Liebeskind DS, Shields R, Nogueira RG, Jovin TG; DAWN Trial Investigators. Impact of Periprocedural and Technical Factors and Patient Characteristics on Revascularization and Outcome in the DAWN Trial. Stroke. 2020 Jan;51(1):247-253. doi: 10.1161/STROKEAHA.119.026437. Epub 2019 Nov 20.

    PubMed 31744425

  • Aghaebrahim A, Jadhav AP, Hanel R, Sauvageau E, Granja MF, Zhang Y, Haussen DC, Budzik RF, Bonafe A, Bhuva P, Ribo M, Cognard C, Sila C, Yavagal D, Hassan AE, Smith WS, Saver J, Liebeskind DS, Nogueira RG, Jovin TG; DAWN Investigators. Outcome in Direct Versus Transfer Patients in the DAWN Controlled Trial. Stroke. 2019 Aug;50(8):2163-2167. doi: 10.1161/STROKEAHA.119.025710. Epub 2019 Jul 15.

    PubMed 31303153

  • Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.

    PubMed 29129157

Questions about this trial

What is this clinical trial studying?

A study testing Trevo Thrombectomy Procedure and Medical Management in people with Ischemic Stroke, run by Stryker Neurovascular at 32 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Spain, France, Australia, Canada. 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?

Yes. Results are posted in the registry (first posted 20 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (time frame: 90 days). The study lists 3 primary outcomes in all. 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 NCT02142283, which also lists 6 linked publications.

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 20 Jul 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in