Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device

Exclusion Criteria

• •General exclusion
• •Patient is a good candidate for and elects open surgical repair
• •Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
• •Is eligible for enrollment in a manufacturer-sponsored investigational device exemption (IDE) at the investigational site
• •Unwilling to comply with the follow-up schedule
• •Inability or refusal to give informed consent by patient or legal representative
• •Patient is pregnant or breastfeeding
• •Patient has a contained rupture
• •Patient has a ruptured aneurysm
• •Patient has a dissection in the treated portion of the aorta
• •Obstructive stenting of any or all of the visceral vessels
• •Known sensitivities or allergies to the materials of construction of the devices, including nitinol (Nickel: Titanium), polyester, platinum-iridium, polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel.
• •Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
• •Uncorrectable coagulopathy
• •Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
• •Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned \< 30 days of the endovascular repair
• •Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
• •Systemic or local infection that may increase the risk of endovascular graft infection
• •Baseline creatinine greater than 2.0 mg/dL
• •History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)
• •Thrombus or excessive calcification within the neck of the aneurysm
• •Branch stenosis ≥ 70%
• •Anatomy that would not allow maintenance of at least one patent hypogastric artery
• •Anatomy that would not allow primary or assisted patency of the left subclavian artery