Condition:
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.
Dates: October 2006 -
Study Status: Recruiting
Ages Eligible: 21 Years - 85 Years
Gender Eligible: Both
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
Sponsor:
Phase: Phase 2/Phase 3
First Received: August 27, 2007
Last Updated: July 29, 2009
Clinicaltrials.gov ID:
NCT00522535
Study HIC # 0802003478
Condition:
Interventions: Procedure: Open repair;
Procedure: EVAR
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.
Dates: October 2006 -
Study Status: Recruiting
Ages Eligible: 21 Years - 85 Years
Gender Eligible: Both
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
Sponsor:
Phase: Phase 2/Phase 3
First Received: August 27, 2007
Last Updated: July 29, 2009
Clinicaltrials.gov ID:
NCT00522535
Study HIC # 0802003478
Svetlana Vassilieva, MD
203-785-5182
svetlana.vassilieva@yale.edu
Bart Muhs, MD
Principal Investigator
HIC # 0805003779
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