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| ID | Type | Description | Link |
|---|---|---|---|
| G220131/S001 | Other Identifier | U.S. Food and Drug Administration Center for Devices and Radiological Health |
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Prospective, multi-center, single-arm early feasibility study enrolling a minimum of 15 subjects at up to a minimum of 3 active investigational sites in the United States.
The subjects must be diagnosed with acute ischemic stroke (AIS), must be post-mechanical thrombectomy, will have had intravenous thrombolytics, and have a visible MCA, ACA or PCA occlusive clot on initial angiographic imaging.
Each subject will receive the Pulse NanoMED procedure after attempted neurovascular therapy to achieve better reperfusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group/Cohort | Experimental | Subjects presenting to the emergency department with AIS, eligible for thrombolytic therapy, and with evidence of an occlusive clot by angiographic imaging will be considered for inclusion in the study. Post-thrombolytic therapy and mechanical thrombectomy eligible Subjects will receive the experimental NanoMED device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse NanoMED System | Device | The Pulse NanoMED System is comprised of iron nanoparticles and a small, portable, magnetic Workstation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Objective | To test the safety and feasibility of the Pulse NanoMED System in ischemic stroke patients. The potential clinical benefit of early recanalization will be visually assessed by a core laboratory by comparing baseline DSA, CTA, or MRA images with images taken at set timepoints. | 24 hours, 7 days (or discharge, if earlier), 30 days, and 90 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Objective | To test the hypothesis that ischemic stroke patients that receive thrombolytic therapy and endovascular therapy will have improved reperfusion as assessed by eTICI and clinical outcomes when provided adjunctive treatment with the Pulse NanoMED System. | 24 hours, 7 days (or discharge, if earlier), 30 days, and 90 days post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristen Hlozek, PhD | Contact | 857-334-0851 | kristen@euphratesvascular.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina - Prisma | Recruiting | Columbia | South Carolina | 29203 | United States |
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| ID | Term |
|---|---|
| D002539 | Cerebral Arterial Diseases |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Prospective, multi-center, single-arm early feasibility study.
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |