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A prospective, open label single arm feasibility study to evaluate the safety and performance of the Magneto Microcatheter in patients diagnosed with acute ischemic stroke and planned for thrombectomy procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magneto Microcatheter | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magneto Microcatheter | Device | All patients will be treated with Magneto Microcatheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the safety of Magneto Microcatheter in the acute post procedure duration by assessing the incidence of device related Serious Adverse Events within 24 hours post procedure | Occurrence of device related Serious Adverse Events | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the safety of Magneto Microcatheter by assessing the incidence of device related Serious Adverse Events within 90 days post procedure | Occurrence of device related Serious Adverse Events | 90 days |
| Evaluation of the performance of Magneto Microcatheter by assessing its ability to remove the clot and evaluating its ease of use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Marzelik | Sheba Medical Center | Principal Investigator |
| Dr.Amsalem | Shaare Zedek, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Mental Health, Neurology and Neurosurgery) | Budapest | Hungary | ||||
| Shaare Zedek |
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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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Assessment of device performance in clot removal (TICI scale to evaluate revascularization) and ease of use (questionnaire that will be completed by the treating physician post procedure) |
| During Procedure |
| Jerusalem |
| Israel |
| Sheba Medical Center | Ramat Gan | Israel |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |