|
|
View Clinical Trial (Medical Research Study)
|
Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft - NCT00522535-06510 (Clinical Trial 181683)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy181683.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| 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: |
|
November 3, 2009 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|
|
|
|