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Purpose of this study: The purpose of the study is to evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the treatment of abdominal aortic, aorto-iliac and common iliac aneurysms with anatomies including angled aorta, angled aneurysmal body, or both, between 0° and 90°.
Study hypothesis: The primary efficacy hypothesis is the proportion of grafts remaining free from endoleak, migration, and fracture at 12 months.
Efficacy: The 12 month, all cause mortality rate in the Aorfix™ group will be non-inferior to the 12 month, all cause mortality rate in the Open Control group.
Safety: The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups will be non-inferior to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Surgical Repair | Active Comparator | Open surgical repair of abdominal aortic aneurysm. All patient enrollment and 2-year follow-ups completed. |
|
| Endovascular Repair | Experimental | Endovascular treatment arm of 160 patients having suitable anatomy for the Aorfix™ AAA Flexible Stent Graft System. Use of stent grafts in aortic angles greater than 60° has not been approved for other devices available in the US. As a result, a minimum of 120 patients in this arm will have an aortic angle between 60° and 90°. Patient recruitment completed; 5-year follow-up evaluations continue. |
|
| Continued Access | Experimental | Endovascular treatment arm of 50 patients maximum having suitable anatomy for the Aorfix™ AAA Flexible Stent Graft System. This Arm will provide active sites with ongoing device access while FDA reviews the PMA. Patient recruitment completed; 5-year patient follow-ups continue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open surgical repair | Procedure | Open surgical repair of abdominal aortic aneurysm |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Aorfix™ vs. Open Control All Cause Mortality | The 12 month, all cause mortality rate in the Aorfix™ group compared to all cause mortality rate in the Open Control group. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Aorfix™ vs. Open Control Adverse Events | The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups compared to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Fillinger, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Vascular Surgery | Birmingham | Alabama | 35294 | United States | ||
| University of Arizona, Department of Surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28943010 | Derived | Wang S, Hicks CW, Malas MB. Neck diameter and inner curve seal zone predict endograft-related complications in highly angulated necks after endovascular aneurysm repair using the Aorfix endograft. J Vasc Surg. 2018 Mar;67(3):760-769. doi: 10.1016/j.jvs.2017.07.114. Epub 2017 Sep 21. | |
| 28190716 | Derived | Malas MB, Hicks CW, Jordan WD Jr, Hodgson KJ, Mills JL Sr, Makaroun MS, Belkin M, Fillinger MF; PYTHAGORAS Investigators. Five-year outcomes of the PYTHAGORAS U.S. clinical trial of the Aorfix endograft for endovascular aneurysm repair in patients with highly angulated aortic necks. J Vasc Surg. 2017 Jun;65(6):1598-1607. doi: 10.1016/j.jvs.2016.10.120. Epub 2017 Feb 9. |
| Label | URL |
|---|---|
| Lombard Medical Technologies Inc. Homepage | View source |
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| Stent Graft |
| Device |
Endovascular repair of abdominal aortic aneurysm (EVAR) |
|
|
| Tucson |
| Arizona |
| 85724 |
| United States |
| Long Beach VA Healthcare System | Long Beach | California | 90822 | United States |
| UCSF Division of Vascular Surgery | San Francisco | California | 94143 | United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Christiana Hospital | Newark | Delaware | 19718 | United States |
| Holy Cross Hospital, Jim Moran Heart & Vascular Research Institute | Fort Lauderdale | Florida | 33308 | United States |
| University of Florida | Gainesville | Florida | 32610-0128 | United States |
| Baptist Hospital of Miami, Cardiac & Vascular Institute | Miami | Florida | 33176 | United States |
| Macon Cardiovascular Institute | Macon | Georgia | 31201 | United States |
| Methodist Heart Lung & Vascular Institute | Peoria | Illinois | 61606 | United States |
| Springfield Memorial Hospital | Springfield | Illinois | 62702 | United States |
| John Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan, Department of Vascular Surgery | Ann Arbor | Michigan | 48109 | United States |
| Michigan Vascular Group | Flint | Michigan | 48507 | United States |
| Abbott Northwestern / MHIF | Minneapolis | Minnesota | 55407 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Dartmouth - Hitchcock Medical | Lebanon | New Hampshire | 03756 | United States |
| Englewood Hospital & Medical Center | Englewood | New Jersey | 07631 | United States |
| Newark-Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| New York Presbyterian-Columbia University Medical Center Division of Vascular Surgery | New York | New York | 10032 | United States |
| Jobst Vascular Center | Toledo | Ohio | 43606 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Pinnacle Health Hospitals | Harrisburg | Pennsylvania | 17110 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232 | United States |
| Moffitt Heart and Vascular Group | Wormleysburg | Pennsylvania | 17043 | United States |
| Sanford Clinic Clinical Research | Sioux Falls | South Dakota | 57117 | United States |
| University of Tennessee | Chattanooga | Tennessee | 37403 | United States |
| DeBakey Heart Center, Methodist Hospital | Houston | Texas | 77030 | United States |
| Sentara Heart Hospital - Vascular & Transplant Specialists | Norfolk | Virginia | 23507 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Sacred Heart Medical Center | Spokane | Washington | 99204 | United States |
| University of Wisconsin School of Medicine & Public Health | Madison | Wisconsin | 53792 | United States |
| 26321596 | Derived | Malas MB, Jordan WD, Cooper MA, Qazi U, Beck AW, Belkin M, Robinson W, Fillinger M. Performance of the Aorfix endograft in severely angulated proximal necks in the PYTHAGORAS United States clinical trial. J Vasc Surg. 2015 Nov;62(5):1108-17. doi: 10.1016/j.jvs.2015.05.042. Epub 2015 Aug 28. |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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