View Clinical Trial (Medical Research Study)

Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft - NCT00522535-06510(Clinical Trial 181683)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  New Haven
State:  
CT
Zip Code: 06510
Conditions: Abdominal Aortic Aneurysms
Purpose: 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.In aneurysms with anatomy including angled aorta, angled aneurysmal body or both between 0° and 90°, where the patients have suitable anatomy. The aortic neck extends from the renal artery furthest from the heart to the top of the aneurysm. Study hypotheses Efficacy The twelve month, all cause mortality rate in the Aorfix™ group will be non-inferior to the twelve month, all cause mortality rate in the control group. Safety The rates of early serious adverse events, as defined in Section 3.3.2, 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 control group.
Study summary:
Criteria: Inclusion Criteria: - Diagnosed abdominal aortic aneurysm > 4.5 cm in diameter, OR 4.0 cm or larger in diameter if symptomatic (i.e. pain, embolisation), 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 >85 years, or not expected to live more than 2 years from enrolment - 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
Study is available at: Yale University School of Medicine 333 Cedar Street FMB 137, Section of Vascular Surgery
New Haven, CT 06510
United States

Primary Contact:
Svetlana Vassilieva, MD
Email: svetlana.vassilieva@yale.edu
Phone: 203-785-5182
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.