The primary study objective is to determine if subjects experiencing an acute ischemic stroke due to large vessel occlusion, treated with combined IV t-PA and Solitaire Revascularization Device within 6 hours of symptom onset have less stroke-related neurological disability (mRS) than those subjects treated with IV t-PA alone
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
196
Standard therapy with Intravenous (IV) recombinant human tissue plasminogen activator (rtPA)
Clot retrieval with the Solitaire revascularization device after patients have received standard therapy with intravenous tissue plasminogen activator
Kaleida Health/Buffalo General
Buffalo, New York, United States
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).
mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. 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
Death Due to Any Cause at 90 Days
Time frame: 90 days
Functional Independence as Defined by Modified Rankin Scale (mRS) Score ≤2 at 90 Days
Time frame: 90 days
Change in NIH Stroke Scale Score at 27 ± 6 Hrs Post Randomization
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.
Time frame: Baseline to 27±6 hours post randomization
Volume of Cerebral Infarction as Measured by a CT or MRI Scan at 27±6 Hours Post Randomization
Time frame: 27±6 hours post randomization
Reperfusion Measured by Reperfusion Ratio on CT or MRI Scan 27±6 Hours Post Randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 27±6 hours post randomization
Arterial Revascularization Measured by TICI 2b or 3 Following Device Use
Time frame: Post procedure
Correlation of RAPID-assessed Core Infarct Volume With 27±6 Hours Post Randomization Stroke Infarction in Subjects Who Achieved TICI 2b-3 Reperfusion Without Intracranial Hemorrhage
Time frame: 27±6 hours post randomization