Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft (PYTHAGORAS)

Lombard Medical

Status: Completed

Conditions: Abdominal Aortic Aneurysms

Treatments: Procedure: Open surgical repair; Device: Stent Graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT00522535

PYTHAGORAS

Details and patient eligibility

About

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.

Enrollment: 230 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 3 patient groups

Open Surgical Repair

Active Comparator group

Description:

Open surgical repair of abdominal aortic aneurysm. All patient enrollment and 2-year follow-ups completed.

Treatment:

Procedure: Open surgical repair

Endovascular Repair

Experimental group

Description:

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.

Treatment:

Device: Stent Graft

Continued Access

Experimental group

Description:

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.

Treatment:

Device: Stent Graft