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| Name | Class |
|---|---|
| Stryker Neurovascular | INDUSTRY |
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To compare the safety and efficacy of treating small aneurysms with coils specially designed for small aneurysms to historically reported rates of safety and efficacy for the treatment of larger aneurysms.
This is a prospective cohort study whereby patients who undergo endovascular treatment with coils for intracranial aneurysms will be studied for initial procedural and 12-18 month post-treatment outcome. The procedural failure rate (defined above) of treating small aneurysms with specially designed coils will be compared to pre-specified historical occurrences. This evaluation will occur within the framework of "non-inferiority" (i.e. comparable success to coiling of large aneurysms).
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| Measure | Description | Time Frame |
|---|---|---|
| Procedural failure | Defined as the composite of technical failure (inability to coil the aneurysm), and complication leading to permanent neurologic injury or death. The second primary outcome relates to the long term effectiveness of the procedure, and is defined as freedom from angiographic recurrence within a period of 12-18 months after the index procedure. | 18 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with cerebral aneurysms less than 4mm
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire L McKinley, CCRP | Contact | 434-924-9271 | cw9ne@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Avery J Evans, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Barbara Cottage Hospital | Recruiting | Santa Barbara | California | 93105 | United States |
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| Radiology Imaging Associates | Recruiting | Englewood | Colorado | 80112 | United States |
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| University of Florida | Recruiting | Gainesville | Florida | 32610 | United States |
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| Lyerly Neurosurgery, Affiliate of Baptist Health | Recruiting | Jacksonville | Florida | 32207 | United States |
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| Norton Neuroscience Institute | Recruiting | Louisville | Kentucky | 40241 | United States |
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| Maine Medical Center | Recruiting | Scarborough | Maine | 04074 | United States |
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| University of Massachusettes | Recruiting | Worcester | Massachusetts | 01655 | United States |
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| Abbott Northwestern Hospital | Recruiting | Minneapolis | Minnesota | 55407 | United States |
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| Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| The University of Oklahoma Health Sciences Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
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| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| University of Virginia | Recruiting | Charlottesville | Virginia | 22908 | United States |
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| Riverside Research and Discovery- Riverside Health System | Recruiting | Newport News | Virginia | 23601 | United States |
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| Sentara Neuroscience Institute | Recruiting | Virginia Beach | Virginia | 23456 | United States |
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| Swedish Neurosciences Research | Recruiting | Seattle | Washington | 98122 | United States |
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| Aurora Research Institute | Recruiting | Milwaukee | Wisconsin | 53233 | United States |
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| CHUM - Hôpital Notre-Dame Hospital | Recruiting | Montreal | Quebec | QC H2L 4M1 | Canada |
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| University of Saskatchewan | Recruiting | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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