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| Name | Class |
|---|---|
| University at Buffalo | OTHER |
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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
The neurological thrombectomy device is an investigational device
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neurological thrombectomy device | Experimental | Revascularization device is an investigational device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neurological thrombectomy device is an investigational device. | Device | Revascularization device is an investigational device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate technical efficacy outcomes with radiographical measurements | The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score | Day 1 |
| outcomes with radiographical measurements | The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate technical efficacy outcomes with radiographical measurements | The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score | Day 3 |
| Evaluate technical efficacy outcomes with radiographical measurements |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| kaledia Health/Buffalo General Medical Center/GVI | Buffalo | New York | 14203 | United States |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score |
| 90 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |