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Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
NCT00522535 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- PROCEDURE Open surgical repair
- DEVICE Stent Graft
Study Locations (20)
California
- Long Beach VA Healthcare System — Long Beach
- UCSF Division of Vascular Surgery — San Francisco
- Stanford University Medical Center — Stanford
- Harbor-UCLA Medical Center — Torrance
Florida
- Holy Cross Hospital, Jim Moran Heart & Vascular Research Institute — Fort Lauderdale
- University of Florida — Gainesville
- Baptist Hospital of Miami, Cardiac & Vascular Institute — Miami
Illinois
- Methodist Heart Lung & Vascular Institute — Peoria
- Springfield Memorial Hospital — Springfield
Michigan
- University of Michigan, Department of Vascular Surgery — Ann Arbor
- Michigan Vascular Group — Flint
Alabama
- UAB Vascular Surgery — Birmingham
Arizona
- University of Arizona, Department of Surgery — Tucson
Connecticut
- Yale University School of Medicine — New Haven
Delaware
- Christiana Hospital — Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2006-04 |
| Est. Completion | 2020-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00522535
The ClinicalTrials.gov registry entry for NCT00522535 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lombard Medical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Abdominal Aortic Aneurysms appearing as the primary indexed condition, and to 2 interventions — of which Open surgical repair is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00522535 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00522535 about?
NCT00522535 is a clinical study titled "Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft". 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 bod...
What is the current status of trial NCT00522535?
This trial is currently completed. It is a NA study. The enrollment target is 230 participants. The study started on 2006-04. Estimated completion is 2020-07.
What conditions does trial NCT00522535 study?
This clinical trial studies the following conditions: Abdominal Aortic Aneurysms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00522535?
The interventions under investigation include: Open surgical repair (PROCEDURE), Stent Graft (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00522535?
This trial is sponsored by Lombard Medical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00522535 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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