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NCT00522535 · ClinicalTrials.gov registry record · NA
Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
A NA study of Abdominal Aortic Aneurysms, sponsored by Lombard Medical.
- Completed
- Registry status
- NA
- Development phase
- 230
- Enrollment target
- 20
- Study locations
NCT00522535: Completed NA study of Abdominal Aortic Aneurysms, sponsored by Lombard Medical.
NCT00522535 is a NA study of Abdominal Aortic Aneurysms that has completed, run by Lombard Medical. The registered enrollment target is 230 participants, above the 157-participant average among 5 other Abdominal Aortic Aneurysms trials with a reported enrollment target (46% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00522535, a NA study of Abdominal Aortic Aneurysms, has completed, sponsored by Lombard Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 230 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The 12 month, all cause mortality rate in the Aorfix™ group compared to all cause mortality rate 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 |
What the finished NCT00522535 record still lists
NCT00522535 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, above the 157-participant average among 5 other Abdominal Aortic Aneurysms trials with a reported enrollment target (46% higher).
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.
NCT00522535 names 20 study sites across 13 states, led by California, Florida, Illinois.
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.
What interventions are being tested in trial NCT00522535?
The interventions under investigation include: Open surgical repair (PROCEDURE), Stent Graft (DEVICE).
Who is sponsoring clinical trial NCT00522535?
This trial is sponsored by Lombard Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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