Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
This trial is active, not recruiting.
|Condition||abdominal aortic aneurysms|
|Treatments||open surgical repair, stent graft|
|Start date||April 2006|
|End date||September 2011|
|Trial size||210 participants|
|Trial identifier||NCT00522535, PYTHAGORAS|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Birmingham, AL||UAB Vascular Surgery||no longer recruiting|
|Tucson, AZ||University of Arizona, Department of Surgery||no longer recruiting|
|Long Beach, CA||Long Beach VA Healthcare System||no longer recruiting|
|San Francisco, CA||UCSF Division of Vascular Surgery||no longer recruiting|
|Stanford, CA||Stanford University Medical Center||no longer recruiting|
|Torrance, CA||Harbor-UCLA Medical Center||no longer recruiting|
|New Haven, CT||Yale University School of Medicine||no longer recruiting|
|Newark, DE||Christiana Hospital||no longer recruiting|
|Ft. Lauderdale, FL||Holy Cross Hospital, Jim Moran Heart & Vascular Research Institute||no longer recruiting|
|Gainesville, FL||University of Florida||no longer recruiting|
|Miami, FL||Baptist Hospital of Miami, Cardiac & Vascular Institute||no longer recruiting|
|Macon, GA||Macon Cardiovascular Institute||no longer recruiting|
|Peoria, IL||Methodist Heart Lung & Vascular Institute||no longer recruiting|
|Springfield, IL||Springfield Memorial Hospital||no longer recruiting|
|Baltimore, MD||John Hopkins Bayview Medical Center||no longer recruiting|
|Boston, MA||Brigham and Women's Hospital||no longer recruiting|
|Ann Arbor, MI||University of Michigan, Department of Vascular Surgery||no longer recruiting|
|Flint, MI||Michigan Vascular Group||no longer recruiting|
|Minneapolis, MN||Abbott Northwestern / MHIF||no longer recruiting|
|St Louis, MO||Washington University||no longer recruiting|
|Lebanon, NH||Dartmouth - Hitchcock Medical||no longer recruiting|
|Englewood, NJ||Englewood Hospital & Medical Center||no longer recruiting|
|Newark, NJ||Newark-Beth Israel Medical Center||no longer recruiting|
|Albany, NY||Albany Medical Center||no longer recruiting|
|New York, NY||New York Presbyterian-Columbia University Medical Center Division of Vascular Surgery||no longer recruiting|
|Toledo, OH||Jobst Vascular Center||no longer recruiting|
|Portland, OR||Oregon Health & Science University||no longer recruiting|
|Danville, PA||Geisinger Medical Center||no longer recruiting|
|Harrisburg, PA||Pinnacle Health Hospitals||no longer recruiting|
|Pittsburgh, PA||University of Pittsburgh||no longer recruiting|
|Wormleysburg, PA||Moffitt Heart and Vascular Group||no longer recruiting|
|Sioux Falls, SD||Sanford Clinic Clinical Research||no longer recruiting|
|Chattanooga, TN||University of Tennessee||no longer recruiting|
|Houston, TX||DeBakey Heart Center, Methodist Hospital||no longer recruiting|
|Norfolk, VA||Sentara Heart Hospital - Vascular & Transplant Specialists||no longer recruiting|
|Seattle, WA||Swedish Medical Center||no longer recruiting|
|Spokane, WA||Sacred Heart Medical Center||no longer recruiting|
|Madison, WI||University of Wisconsin School of Medicine & Public Health||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
The 12 month, all cause mortality rate in the Aorfix™ group compared to all cause mortality rate in the Open Control group.
time frame: 1 year
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.
time frame: 30 days
Male or female participants at least 21 years old.
Inclusion Criteria: - Diagnosed abdominal aortic aneurysm > 4.5 cm in diameter, OR 4.0 cm or larger in diameter if symptomatic (i.e. pain, embolization), OR documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery (ies), and/or - Iliac aneurysm greater than, or equal to 3.5 cm in maximum diameter. Exclusion Criteria: - Less than 21 years of age, - Life expectancy less than 2 years, - Pregnant, - Religious cultural or other objection to the receipt of blood or blood products, - Unwilling to comply with follow-up schedule, - Unwillingness or inability to provide informed consent to both trial and procedure. - Patients not expected to live more than 2 years from enrollment - Patient has a ruptured aneurysm - Aneurysm extends above renal arteries - Proximal neck of aneurysm has significant loose thrombus associated with it - Patient with an acute or chronic aortic dissection or mycotic aneurysm - Patient has current non-localized infection (may be recruited following remission of the infection) - Patient is allergic to device materials - Patient is allergic to or intolerant of use of contrast media and cannot be exposed to suitable remedial treatment such as steroids and/or benadryl - Patient is clinically and morbidly obese such that imaging would be severely adversely affected - Patient has renal failure (serum creatinine > 2.5 mg/dL) - Patient has an uncorrectable bleeding abnormality - Patient has unstable angina - Patient is receiving dialysis: - Inflammatory aneurysm - MI in last 6 months - End stage COPD - Patient has connective tissue disease (eg Marfan syndrome, Ehlers-Danlos syndrome) - Significant (>80%) renal artery stenosis which cannot be readily treated
|Official title||Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft|
|Principal investigator||Mark Fillinger, MD|
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