Assessing the Safety and Effectiveness of a Neurological Thrombectomy Medical Device for Acute Ischemic Stroke
- Conditions
- Ischemic Stroke
- Registration Number
- NCT05074186
- Lead Sponsor
- University at Buffalo
- Brief Summary
The Jacobs Institute is participating in a Sponsor Investigator study designed to collect prospective clinical evidence to evaluate the use of a neurological thrombectomy device for clot retrieval in acute ischemic patients
- Detailed Description
The neurological thrombectomy device is an investigational device
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
at least 18 years of age at time of consent Has baseline National Institutes of Health Stroke Scale (NIHSS) ≥ 8; Able to be treated within 8 hours of stroke symptom onset or Last Known Normal (LKN);
Cannot provide consent or legally authorized representative not available to provide consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Evaluate technical efficacy outcomes with radiographical measurements Day 1 The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score
outcomes with radiographical measurements day 1 The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score
- Secondary Outcome Measures
Name Time Method Evaluate technical efficacy outcomes with radiographical measurements 90 days The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score
Related Research Topics
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Trial Locations
- Locations (1)
kaledia Health/Buffalo General Medical Center/GVI
🇺🇸Buffalo, New York, United States
kaledia Health/Buffalo General Medical Center/GVI🇺🇸Buffalo, New York, United States