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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
206
stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)
Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
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
Time frame: 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
Time frame: 90 days
Stroke-related Mortality, Primary Safety Outcome
Time frame: 90 days
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
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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
...and 22 more locations
Time frame: 90 days
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.
Time frame: 5-7 Days
All Cause Mortality
Time frame: 90 days
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.
Time frame: 24 hours
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.
Time frame: 5-7 days