Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
Public ClinicalTrials.gov record NCT00522535. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00522535
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 230 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2006 (Type not available)
- Primary completion
- Sep 2011 (Actual)
- Completion
- Jul 2020 (Actual)
- Last update posted
- Oct 26, 2021
2006 – 2020
United States locations
- U.S. sites
- 38
- U.S. states
- 25
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Vascular Surgery | Birmingham | Alabama | 35294 | — |
| University of Arizona, Department of Surgery | Tucson | Arizona | 85724 | — |
| Long Beach VA Healthcare System | Long Beach | California | 90822 | — |
| UCSF Division of Vascular Surgery | San Francisco | California | 94143 | — |
| Stanford University Medical Center | Stanford | California | 94305 | — |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | — |
| Christiana Hospital | Newark | Delaware | 19718 | — |
| Holy Cross Hospital, Jim Moran Heart & Vascular Research Institute | Fort Lauderdale | Florida | 33308 | — |
| University of Florida | Gainesville | Florida | 32610-0128 | — |
| Baptist Hospital of Miami, Cardiac & Vascular Institute | Miami | Florida | 33176 | — |
| Macon Cardiovascular Institute | Macon | Georgia | 31201 | — |
| Methodist Heart Lung & Vascular Institute | Peoria | Illinois | 61606 | — |
| Springfield Memorial Hospital | Springfield | Illinois | 62702 | — |
| John Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan, Department of Vascular Surgery | Ann Arbor | Michigan | 48109 | — |
| Michigan Vascular Group | Flint | Michigan | 48507 | — |
| Abbott Northwestern / MHIF | Minneapolis | Minnesota | 55407 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Dartmouth - Hitchcock Medical | Lebanon | New Hampshire | 03756 | — |
| Englewood Hospital & Medical Center | Englewood | New Jersey | 07631 | — |
| Newark-Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| New York Presbyterian-Columbia University Medical Center Division of Vascular Surgery | New York | New York | 10032 | — |
| Jobst Vascular Center | Toledo | Ohio | 43606 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Pinnacle Health Hospitals | Harrisburg | Pennsylvania | 17110 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232 | — |
| Moffitt Heart and Vascular Group | Wormleysburg | Pennsylvania | 17043 | — |
| Sanford Clinic Clinical Research | Sioux Falls | South Dakota | 57117 | — |
| University of Tennessee | Chattanooga | Tennessee | 37403 | — |
| DeBakey Heart Center, Methodist Hospital | Houston | Texas | 77030 | — |
| Sentara Heart Hospital - Vascular & Transplant Specialists | Norfolk | Virginia | 23507 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
| Sacred Heart Medical Center | Spokane | Washington | 99204 | — |
| University of Wisconsin School of Medicine & Public Health | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00522535, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 26, 2021 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00522535 live on ClinicalTrials.gov.