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| ID | Type | Description | Link |
|---|---|---|---|
| SHIELD | Other Identifier | Jacobs Institute |
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The Jacobs Institute is participating in a study designed to collect prospective clinical evidence to evaluate the approved use of the Pipelineâ„¢ Flex Embolization Device with Shield Technologyâ„¢ for the endovascular treatment of adults (22 years of age or older) with wide-necked intracranial aneurysms
The Pipeline™ Flex Embolization Device with Shield Technology™ for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments. The Pipeline™ Flex Embolization Device with Shield Technology™ is also indicated for use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width ≥ 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysm (IAs) arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHIELD Study Arm | Other | Active treatment with the Pipeline SHIELD Device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHIELD | Device | Pipeline SHIELD device under study |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of thromboembolic event(s) | The Pipeline™ Flex Embolization Device with Shield Technology™ for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments. The Pipeline™ Flex Embolization Device with Shield Technology™ is also indicated for use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width ≥ 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysm (IAs) arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos Pena, PhD, MS | Contact | 2404810824 | cpena@jacobsinstitute.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacobs Institute | Recruiting | Buffalo | New York | 14203 | United States |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Surgical System Intervention
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