Ischemic Stroke
Conditions
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
Interventions
DEVICEneurological thrombectomy device is an investigational device.
Revascularization device is an investigational device.
Sponsors
University at Buffalo
Jacobs institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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);
Exclusion criteria
Cannot provide consent or legally authorized representative not available to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate technical efficacy outcomes with radiographical measurements | Day 3 | The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score |
Countries
United States
Outcome results
None listed