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The data collected in this study will be used to support International Regulatory submissions. The study objective is to evaluate the continued safety and efficacy of the AXIUM Progressive Coil System.
This Device has been used clinically at approximately 150 Institutions under FDA 510(k) clearance since April 24, 2007. The device received CE authorization on June 30, 2007. Through December 2007, more than 1000 patients have been treated with the AXIUM Coils.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXIUM Coils |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The AXIUM Progressive Coil System | Device | Embolization of aneurysm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Occlusion | Defined in protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity/Mortality | Defined in protocol |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with intracranial aneurysm, either ruptured or un-ruptured, with aneurysm has a maximum diameter of 2mm to 20mm
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| Name | Affiliation | Role |
|---|---|---|
| Ajay K Wakhloo, MD, PhD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lac+Usc/Uscuh | Los Angeles | California | 90089 | United States | ||
| Vascular and Interventional Specialists of Orange County, Inc. - St. Joseph Hospital of Orange |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8315465 | Background | Casasco AE, Aymard A, Gobin YP, Houdart E, Rogopoulos A, George B, Hodes JE, Cophignon J, Merland JJ. Selective endovascular treatment of 71 intracranial aneurysms with platinum coils. J Neurosurg. 1993 Jul;79(1):3-10. doi: 10.3171/jns.1993.79.1.0003. | |
| 17698550 | Background | Wakhloo AK, Gounis MJ, Sandhu JS, Akkawi N, Schenck AE, Linfante I. Complex-shaped platinum coils for brain aneurysms: higher packing density, improved biomechanical stability, and midterm angiographic outcome. AJNR Am J Neuroradiol. 2007 Aug;28(7):1395-400. doi: 10.3174/ajnr.A0542. |
| Label | URL |
|---|---|
| ev3 Inc. | View source |
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| Orange |
| California |
| 92868 |
| United States |
| Lee Memorial Health System | Fort Myers | Florida | 33908 | United States |
| University of Miami - Jackson Memorial Hospital Systems | Miami | Florida | 33136 | United States |
| Bayfront Medical Center | St. Petersburg | Florida | 33701 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Neurologic & Orthopedic Hospital of Chicago (NOHC) | Chicago | Illinois | 60640 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Massachusetts Medical Center | Worcester | Massachusetts | 01655 | United States |
| Abbott Northwestern | Minneapolis | Minnesota | 55407 | United States |
| Kaleida Health - Millard Fillmore | Buffalo | New York | 14209 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Oregon Health & Science University (OHSU) | Portland | Oregon | 97239 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | United States |
| Palmetto Richland Health Memorial Hospital | Columbia | South Carolina | 29203 | United States |
| Fletcher Allen Health Care | Burlington | Vermont | 05401-1473 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| 17322071 | Background | Linfante I, Wakhloo AK. Brain aneurysms and arteriovenous malformations: advancements and emerging treatments in endovascular embolization. Stroke. 2007 Apr;38(4):1411-7. doi: 10.1161/01.STR.0000259824.10732.bb. Epub 2007 Feb 22. |
| 15206430 | Background | Razack N, Thompson BG. Treatment of intracranial aneurysms: clipping or coiling? J Neuroophthalmol. 2004 Mar;24(1):1-2. doi: 10.1097/00041327-200403000-00001. No abstract available. |
| 16575325 | Background | Mericle RA, Reig AS, Burry MV, Eskioglu E, Firment CS, Santra S. Endovascular surgery for proximal posterior inferior cerebellar artery aneurysms: an analysis of Glasgow Outcome Score by Hunt-Hess grades. Neurosurgery. 2006 Apr;58(4):619-25; discussion 619-25. doi: 10.1227/01.NEU.0000204127.81249.28. |
| 11844258 | Background | Thornton J, Debrun GM, Aletich VA, Bashir Q, Charbel FT, Ausman J. Follow-up angiography of intracranial aneurysms treated with endovascular placement of Guglielmi detachable coils. Neurosurgery. 2002 Feb;50(2):239-49; discussion 249-50. doi: 10.1097/00006123-200202000-00003. |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D020765 | Intracranial Arterial Diseases |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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