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The ASPIRe registry was stopped after only 200 patients were enrolled as this was deemed sufficient to confirm the safety event rates that had recently been identified in the lntrePED registry.
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The primary objective of this study is to further expand the body of clinical knowledge in patients undergoing Pipeline Embolization Device (Pipeline or PED) placement for intracranial aneurysms (IAs or ICAs) according to Pipeline's labeled indication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aneurysms treated with Pipleline | Aneurysms treated with Pipleline. All patients independently treated according to the labeled indications for use with the Pipeline Embolization Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pipeline Embolization Device | Device | Aneurysms treated independent of study entry with the Pipeline Embolization Device. This is an observational, non-interventional study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Neurological Adverse Events following PED use | The primary endpoint will consist of a composite of any/all of the events listed below.
| From Device placement until last follow up, for an average of 3 years of follow up for each subject enrolled |
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Inclusion Criteria:
(All sites, All countries)
United States: Additional Inclusion Criteria for subjects enrolled in the United States:
4US) Subjects who are age 22 or higher 5US) IA of at least 10 mm in maximum dimension along the internal carotid artery between the petrous and superior hypophyseal segments
Canada: Additional Inclusion Criteria for subjects enrolled in Canada:
4C) In Canada, the Pipeline™ Embolization Device is intended for use with or without embolic coils for the treatment of complex intracranial aneurysms that are not amenable to treatment with surgical clipping.
5C) Canadian licensing/approval is limited to devices that are between 3.25 mm and 5.00 mm in diameter.
France: Additional Inclusion Criteria for subjects enrolled in France:
4F) Unruptured IA, saccular or fusiform with an aneurysm sac diameter > 15mm and not treatable with other current therapies ( EVT with coils with or without assisting system (intracranial stent) or balloon remodeling, or surgery) due to its specific morphology.
5F) IA previously treated with unruptured recanalization of the aneurismal sac > 7 mm, not treatable with conservative treatment.
Exclusion Criteria: (based on contraindications PED IFU)
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Patients with an intracranial aneurysm meeting the labeled indication for the relevant geography.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Barrow Neurosurgical Associates |
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|
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
| Radiology Imaging Associates / Colorado Neurological Institute | Englewood | Colorado | 80113 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| Neurointerventional Associates, P.A. | St. Petersburg | Florida | 33701 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Neurosurgical Associates at Central Baptist | Lexington | Kentucky | 40503 | United States |
| Norton Neuroscience Institute | Louisville | Kentucky | 40241 | United States |
| Abbott Northwestern Hospital/Consulting Radiologists | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| St. Paul Radiology | Saint Paul | Minnesota | 55102 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| University of Buffalo Neurosurgery, Buffalo General Hospital | Buffalo | New York | 14203 | United States |
| The State University of New York, Stony Brook | Stony Brook | New York | 11794 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| St. Luke's Episcopal Hospital | Houston | Texas | 77030 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| Medical College Of Wisconsin/Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| Clínica La Sagrada Familia | Buenos Aires | C1426EOB | Argentina |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Besançon University Hospital | Besançon | 25030 | France |
| Hôpital Gui de Chauliac | Montpellier | 34295 | France |
| Hôpital Maison Blanche - CHU | Reims | 51100 | France |
| Alfried Krupp Krankenhaus | Essen | 45131 | Germany |
| Klinikum Stuttgart | Stuttgart | 70174 | Germany |
| Niguarda CA Granda Hospital of Milan | Milan | 20162 | Italy |
| Fondazione Istituto Neurologico "Besta" | Milan | 20133 | Italy |
| Ospedale San Giovanni Bosco ASL Napoli 1 Centro | Naples | 80144 | Italy |
| University Hospitals of Geneva (HUG) | Geneva | 1211 | Switzerland |
| 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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