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The purpose of the Pipelineâ„¢ Flex Embolization Device with Shield Technologyâ„¢ Post Approval Study (PAS) ("Pipelineâ„¢ Shield PAS") is to collect on-label use data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipelineâ„¢ Flex Embolization Device with Shield Technologyâ„¢ ("Pipelineâ„¢ Shield Device") in a real-world post approval setting within the United States.
The INSPIRE Pipelineâ„¢ Shield Post Approval Study is an observational, prospective, multi-center, single-arm registry to collect on-label use data in patients undergoing treatment for intracranial aneurysms using the Pipelineâ„¢ Flex Embolization Device with Shield Technologyâ„¢ according to the intended use.
The primary objective of this study is to evaluate the on-label use of the Pipelineâ„¢ Shield Device in patients undergoing treatment for intracranial aneurysms per institutional routine clinical care in a real-world post approval study setting in the U.S.
This study is conducted under the Product Surveillance Registry (NCT01524276) and is a sub-study to the therapy specific Neurovascular Product Surveillance Registry (NCT02988128).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment of Intracranial Aneurysms | Device | Embolization of aneurysms using the Pipelineâ„¢ Flex Embolization Device with Shield Technologyâ„¢ |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the composite outcome (Occlusion of the target aneurysm, Significant parent artery stenosis, Retreatment of the target aneurysm) at 1 year post-procedure. | Incidence at 1-year post-procedure of complete occlusion of the target aneurysm, significant parent artery stenosis ≤ 50%, and no retreatment of the target aneurysm. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients requiring treatment for intracranial aneurysms with the market approved Pipelineâ„¢ Flex Embolization Device with Shield Technologyâ„¢ device are eligible for the registry
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| Name | Affiliation | Role |
|---|---|---|
| Harsh Sancheti | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Yale New Haven Hospital |
No individual participant data will be available
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| New Haven |
| Connecticut |
| 06510 |
| United States |
| Baptist Medical Center Jacksonville | Jacksonville | Florida | 32207 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Endeavor Health - Evanston Hospital | Evanston | Illinois | 60201 | United States |
| Norton Healthcare | Louisville | Kentucky | 40202 | United States |
| Washington University in Saint Louis | St Louis | Missouri | 63130 | United States |
| NYU Langone Medical Center | New York | New York | 10016-6402 | United States |
| Montefiore Medical Center | New York | New York | 10467-2401 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Oklahoma (OU) University Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822-9800 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Prisma Health | Greenville | South Carolina | 29605 | United States |
| Baylor Scott & White Research Institute | Dallas | Texas | 75201 | United States |
| University of Utah Hospital | Salt Lake City | Utah | 84132-0001 | United States |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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