The specific aims of this study are to: 1. Determine whether the endovascular treatment (mechanical thrombectomy) alone without using intravenous (IV) recombinant tissue plasminogen activator (rt-PA) in acute ischemic stroke patients demonstrates "promise" or a lack thereof ("futility") in deciding what would be the next phase III trial. 2. Determine the proportion of subjects with slight or no disability (a modified Rankin score (mRS) of 0-2) at 3 months after receiving endovascular treatment (mechanical thrombectomy) alone without using IV rt-PA and compare with historical controls who were treated with IV rt-PA to identify (or lack of) futility. 3. Determine the proportion of subjects with improvement in the National Institutes of Health Stroke Scale (NIHSS) score of ≥8 points or achieving a score of 0-1 at 24 hours after the onset of stroke among subjects with acute ischemic stroke after receiving endovascular treatment (mechanical thrombectomy) alone without using IV rt-PA. 4. Determine the proportion of subjects with angiographic recanalization on post procedure angiogram according to modified Thrombolysis in Cerebral Infarction (TICI) perfusion flow categories among subjects with acute ischemic stroke after receiving endovascular treatment (mechanical thrombectomy) alone without using IV rt-PA. 5. Determine the proportion of subjects with treatment-related serious adverse events (SAEs) within 72 hours and development of symptomatic intracranial hemorrhage at 27 ±3hrs post treatment among subjects with acute ischemic stroke after receiving endovascular treatment (mechanical thrombectomy) alone without using IV rt-PA.
A phase II trial is proposed to address the question whether administration of intravenous (IV) recombinant tissue plasminogen activator (rt-PA) in acute ischemic stroke patients who are candidates for endovascular treatment provides any additional value. The phase II trial will treat consecutive patients who are candidates for IV rt-PA and mechanical thrombectomy with just mechanical thrombectomy alone. Such trial will generate the necessary data for a definitive phase III trial. The trial is designed based on low rate of recanalization in patients with major arterial occlusion with IV rt-PA alone and no difference in rate of recanalization or distal embolization in patients who receive IV rt-PA and those who do not prior to mechanical thrombectomy. The rates of intracranial hemorrhage (ICH) and cost of hospitalization are higher when IV rt-PA is administered prior to mechanical thrombectomy. The trial will determine the proportion of patients with slight or no disability (a modified Rankin score (mRS) of 0-2) at 3 months after receiving endovascular treatment (mechanical thrombectomy) alone without using IV rt-PA and compare with historical controls who were treated with IV rt-PA to determine futility.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Participants will receive endovascular treatment (mechanical thrombectomy) alone without using IV rt-PA.
University of Missouri
Columbia, Missouri, United States
Favorable Outcome
Modified Rankin Scale (mRS) score of 0-2: 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. The modified Rankin Scale score ranges from 0, indicating no symptoms, to 6, indicating death.
Time frame: 90 days
Angiographic Recanalization
Post procedure angiogram according to modified Thrombolysis in Cerebral Infarction perfusion flow categories: 0 = No perfusion. No antegrade flow beyond the point of occlusion. 1. = Perfusion past the initial obstruction but limited distal branch filling with little or slow distal perfusion 2. A = Perfusion of less than half of the vascular distribution of the occluded artery (eg, filling and perfusion through 1 M2 division) 2B = Perfusion of half or greater of the vascular distribution of the occluded artery (eg, filling and perfusion through 2 or more M2 divisions) 3 = Full perfusion with filling of all distal branches perfusion flow categories
Time frame: Within 6 hours of interventional treatment
Early Neurological Improvement
National Institutes of Health Stroke Scale (NIHSS) score of ≥8 points or achieving a score of 0-1 at 24 hours after the onset of stroke. NIHSS quantifies neurologic deficits in 11 categories. Level of consciousness, horizontal eye movement, visual fields, facial palsy, movement in each limb, sensation, language \& speech, and extinction or inattention on one side of the body are tested. Scores range from 0 to 42, with 0 indicating normal function and higher scores indicating greater deficit severity.
Time frame: 24 hours post enrollment
Quality of Life Status Using Standardized EQ-5D-3L (EuroQol Five Dimension, Three-Level) Questionnaire.
The EQ-5D-3L questionnaire consists of 5 questions in 5 different domains and allows for responses from 1 (the best outcome) to 3 (the worst outcome) in each of five categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Total scores range from 5 to 15, with lower scores indicating better quality of life and a higher score indicating a worse quality of life.
Time frame: 90 days
Quality of Life Status Using EQ VAS (EuroQol Visual Analog Scale) Scores.
EuroQol outcome measurements is a printed 20 cm visual analogue scale (EQ VAS) that appears somewhat like a thermometer, on which a score from 0 (worst imaginable health state or death) to 100 (best imaginable health state) is marked by the patient (or, when necessary, their proxy) with the scale in view.
Time frame: 90 days
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