Safety and Efficacy Study for the Treatment of Abdominal Aortic Aneurysms (UNITE)

Inclusion Criteria:

• Patient is 18 years of age or older

• Patient has a AAA that meets one of the following criteria:

  1. Aneurysm diameter of greater than 4.5 cm, or less than 4.5 cm with rapid expansion
  2. The aneurysm has a saccular configuration where potential for rupture is increased or has exhibited dissection with potential for rupture at, or compromised flow to, vital structures
• The vessels immediately proximal and distal to the lesion are capable of accommodating the study device
• The access artery diameter and profile of the artery are capable of study device delivery.
• Patient has proximal and distal neck lengths of greater than or equal to 1.0 cm
• Patient is willing and able to comply with the follow-up regime.
• Patient has provided written informed consent.

Exclusion Criteria:

• Patient has an aortic diameter greater than 36 mm.
• Patients with ASA score less than 3 and deemed low risk by the Investigator for open surgical repair.
• Patient has an indispensable inferior mesenteric artery.
• Patient has a distal landing zone of < 2 cm in length or > 16 mm in diameter
• Patient has iliac arteries whose tortuosity prevents passage of the introducer catheter.
• If female, patient is pregnant
• Patient has a life expectancy less than two years.
• Patient has an allergy to any of the study device materials
• Patient has coagulopathy or bleeding disorders
• Patient for whom contrast medium or anticoagulation drugs are contraindicated
• Patient has an uncontained rupture of the aneurysm.
• Patient has an active systemic or localized groin infection
• Patient has a connective tissue disease.
• Patient has a GFR < 30 ml/min/1.73m2
• Patient has a circumferential mural thrombus at the implantation site.
• Patient is a candidate for a bifurcated endovascular graft.
• Patient has an aortic trunk with an angle greater than 90°.