The Pythagoras trial is intended to demonstrate the safety and efficacy of the Lombard Medical bifurcated endovascular stent graft (Aorfix) in the treatment of abdominal aortic, aorto-iliac and common iliac aneurysms with necks of up to 60 degrees.
The trial will consist of two arms: an endovascular treatment arm featuring Aorfix in aneurysms with suitable anatomy and a control arm featuring open surgical repair. Follow-up for both arms will be for up to 12 months. Data collection will occur at the pre-, intra-, and post- operative points, and at 30 days, 6 months, and 12 months. Measures of effectiveness and safety are intended to analyze and assess the non-inferiority of Aorfix contrasted to open surgical repair for AAA.