Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo
NCT ID: NCT02142283
Last Updated: 2018-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
206 participants
INTERVENTIONAL
2014-07-31
2017-05-15
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Trevo Thrombectomy Procedure
Trevo Thrombectomy Procedure and Medical Management
Trevo Thrombectomy Procedure
stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)
Medical Management
Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
Medical Management
Medical Management
Medical Management
Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
Interventions
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Trevo Thrombectomy Procedure
stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)
Medical Management
Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Subject has failed IV t-PA therapy (defined as a confirmed persistent occlusion 60 min after administration)
2. Subject is contraindicated for IV t-PA administration
2. Age ≥18
3. Baseline NIHSS ≥10 (assessed within one hour of measuring core infarct volume)
4. Subject can be randomized between with 6 to 24 hours after time last known well
5. No significant pre-stroke disability (pre-stroke mRS must be 0 or 1)
6. Anticipated life expectancy of at least 6 months
7. Subject willing/able to return for protocol required follow up visits
8. 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. \< 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:
1. 0-\<21 cc core infarct and NIHSS ≥ 10 (and age ≥ 80 years old)
2. 0-\<31 cc core infarct and NIHSS ≥ 10 (and age \< 80 years old)
3. 31 cc to \<51 cc core infarct and NIHSS ≥ 20 (and age \< 80 years old)
Exclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Stryker Neurovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Tudor G Jovin, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburg Medical Center Stroke Institute
Raul Nogueira, MD
Role: PRINCIPAL_INVESTIGATOR
Marcus Stroke & Neuroscience Center, Grady Memorial Hospital
Locations
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Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
Christiana Care
Newark, Delaware, United States
Memorial Regional
Hollywood, Florida, United States
Baptist Jacksonville
Jacksonville, Florida, United States
Jackson Memorial/University of Miami
Miami, Florida, United States
Florida Hospital; Neuroscience Research Center
Orlando, Florida, United States
Emory University at Grady Memorial Hospital
Atlanta, Georgia, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
RUSH University Medical Center
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
St. Joseph Mercy - Oakland
Pontiac, Michigan, United States
JFK Neuroscience Institute at JFK Medical Center
Edison, New Jersey, United States
Capital Health System
Trenton, New Jersey, United States
Buffalo General Medical Center
Buffalo, New York, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Riverside Methodist Hospital/ Ohio Health Research Institute
Columbus, Ohio, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
UPMC Stroke Institute
Pittsburgh, Pennsylvania, United States
Erlanger Health System
Chattanooga, Tennessee, United States
Valley Baptist Medical Center-Harlingen
Harlingen, Texas, United States
North Texas Stroke Center HCA (dba TSI)
Plano, Texas, United States
Royal Melbourne
Parkville, , Australia
Toronto Western Hospital - University Health Network
Toronto, Ontario, Canada
Hôpital Gui de Chauliac
Montpellier, , France
Hopital Purpan - Toulouse
Toulouse, , France
Vall d'Hebron Barcelona
Barcelona, , Spain
Hospital Clinic - Barcelona
Barcelona, , Spain
Hospital Germans Trias I Pujol
Barcelona, , Spain
Hospital Universitari de Bellvitge
Barcelona, , Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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T4024
Identifier Type: -
Identifier Source: org_study_id
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