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

NCT02142283 | Completed Results DMC

• 1 other identifier: T4024
• Study Type: interventional
• Target: 206
• Locations: 5 countries
• Sites: 32

Brief 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 seen well.

Conditions

Ischemic Stroke

Keywords

Mechanical thrombectomy; Acute ischemic stroke; Wake up stroke; Late presenting stroke

Outcome Measures

Primary Outcomes (3)

• 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

  90 days

• 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

  90 days

• Stroke-related Mortality, Primary Safety Outcome

  90 days

Secondary Outcomes (5)

• Good Functional Outcome

  90 days

• Early Response

  5-7 Days

• All Cause Mortality

  90 days

• Revascularization Rates

  24 hours

• Neurological Deterioration From Baseline NIHSS Score

  5-7 days

Study Arms (2)

Trevo Thrombectomy Procedure

EXPERIMENTAL

Trevo Thrombectomy Procedure and Medical Management

Device: Trevo Thrombectomy Procedure; Other: Medical Management

Medical Management

ACTIVE COMPARATOR

Medical Management

Other: Medical Management

Interventions

Trevo Thrombectomy Procedure DEVICE

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

Also known as: Trevo ProVue Retriever, Trevo XP ProVue Retriever

Trevo Thrombectomy Procedure

Medical Management OTHER

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

Also known as: Standard of Care

Medical Management; Trevo Thrombectomy Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups:
• Subject has failed IV t-PA therapy (defined as a confirmed persistent occlusion 60 min after administration)
• Subject is contraindicated for IV t-PA administration
• Age ≥18
• Baseline NIHSS ≥10 (assessed within one hour of measuring core infarct volume)
• Subject can be randomized between with 6 to 24 hours after time last known well
• No significant pre-stroke disability (pre-stroke mRS must be 0 or 1)
• Anticipated life expectancy of at least 6 months
• Subject willing/able to return for protocol required follow up visits
• 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.)
• \< 1/3 MCA territory involved, as evidenced by CT or MRI
• Occlusion of the intracranial ICA and/or MCA-M1 as evidenced by MRA or CTA
• Clinical Imaging Mismatch (CIM) defined as one of the following on MR-DWI or CTP-rCBF maps:
• \<21 cc core infarct and NIHSS ≥ 10 (and age ≥ 80 years old)

You may not qualify if:

• History of severe head injury within past 90 days with residual neurological deficit, as determined by medical history
• Rapid improvement in neurological status to an NIHSS \<10 or evidence of vessel recanalization prior to randomization
• 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)
• Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment
• Baseline blood glucose of \<50mg/dL (2.78 mmol) or \>400mg/dL (22.20 mmol)
• Baseline hemoglobin counts of \<7 mmol/L
• Baseline platelet count \< 50,000/uL
• Abnormal baseline electrolyte parameters as defined by sodium concentration \<130 mmol/L, potassium concentration \<3 mEq/L or \>6 mEq/L
• 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
• 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.
• Any active or recent hemorrhage within the past 30 days
• History of severe allergy (more than rash) to contrast medium
• 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
• Female who is pregnant or lactating at time of admission
• Current participation in another investigational drug or device study

Sponsors & Collaborators

• Stryker Neurovascular: lead

Study Sites (32)

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

California Pacific Medical Center

San Francisco, California, 94114, United States

Location

Christiana Care

Newark, Delaware, 19718, United States

Location

Memorial Regional

Hollywood, Florida, 33021, United States

Location

Baptist Jacksonville

Jacksonville, Florida, 32207, United States

Location

Jackson Memorial/University of Miami

Miami, Florida, 33136, United States

Location

Florida Hospital; Neuroscience Research Center

Orlando, Florida, 32803, United States

Location

Emory University at Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

RUSH University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

St. Joseph Mercy - Oakland

Pontiac, Michigan, 48341, United States

Location

JFK Neuroscience Institute at JFK Medical Center

Edison, New Jersey, 08818, United States

Location

Capital Health System

Trenton, New Jersey, 08638, United States

Location

Buffalo General Medical Center

Buffalo, New York, 14203, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44026, United States

Location

Riverside Methodist Hospital/ Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

UPMC Stroke Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Erlanger Health System

Chattanooga, Tennessee, 37377, United States

Location

Valley Baptist Medical Center-Harlingen

Harlingen, Texas, 78550, United States

Location

North Texas Stroke Center HCA (dba TSI)

Plano, Texas, 75075, United States

Location

Royal Melbourne

Parkville, 3050, Australia

Location

Toronto Western Hospital - University Health Network

Toronto, Ontario, Canada

Location

Hôpital Gui de Chauliac

Montpellier, 34295, France

Location

Hopital Purpan - Toulouse

Toulouse, 40031, France

Location

Vall d'Hebron Barcelona

Barcelona, 08035, Spain

Location

Hospital Clinic - Barcelona

Barcelona, 08036, Spain

Location

Hospital Germans Trias I Pujol

Barcelona, 08916, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Spain

Location

Related Publications (6)

• 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.

  PMID: 34850380 DERIVED

• 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.

  PMID: 34727737 DERIVED

• 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.

  PMID: 34281376 DERIVED

• 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.

  PMID: 31744425 DERIVED

• 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.

  PMID: 31303153 DERIVED

• 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.

  PMID: 29129157 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Practice Management, Medical; Standard of Care

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration; Quality Indicators, Health Care; Quality of Health Care; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Cheryl Fontana, Sr. Manager, Clinical Services
• Organization: Stryker Neurovascular

cheryl.fontana1@stryker.com

510-413-2948

Study Officials

• Tudor G Jovin, MD

  University of Pittsburg Medical Center Stroke Institute

  PRINCIPAL INVESTIGATOR

• Raul Nogueira, MD

  Marcus Stroke & Neuroscience Center, Grady Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 20, 2014
• Study Start: July 1, 2014
• Primary Completion: May 15, 2017
• Study Completion: May 15, 2017
• Last Updated: July 20, 2018
• Results First Posted: July 20, 2018

Record last verified: 2018-07

Locations

US (24); AU (1); FR (2); CA (1); ES (4)