Overview

This trial is active, not recruiting.

Condition abdominal aortic aneurysms
Treatments open surgical repair, stent graft
Sponsor Lombard Medical
Start date April 2006
End date September 2011
Trial size 210 participants
Trial identifier NCT00522535, PYTHAGORAS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Open surgical repair of abdominal aortic aneurysm. All patient enrollment and 2-year follow-ups completed.
open surgical repair
Open surgical repair of abdominal aortic aneurysm
(Experimental)
Endovascular treatment arm of 160 patients having suitable anatomy for the Aorfix™ AAA Flexible Stent Graft System. Use of stent grafts in aortic angles greater than 60° has not been approved for other devices available in the US. As a result, a minimum of 120 patients in this arm will have an aortic angle between 60° and 90°. Patient recruitment completed; 5-year follow-up evaluations continue.
stent graft Aorfix™ stent graft
Endovascular repair of abdominal aortic aneurysm (EVAR)
(Experimental)
Endovascular treatment arm of 50 patients maximum having suitable anatomy for the Aorfix™ AAA Flexible Stent Graft System. This Arm will provide active sites with ongoing device access while FDA reviews the PMA. Patient recruitment completed; 5-year patient follow-ups continue.
stent graft Aorfix™ stent graft
Endovascular repair of abdominal aortic aneurysm (EVAR)

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

Official title Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
Principal investigator Mark Fillinger, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Lombard Medical.