GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms

This is a prospective, non-randomized study designed to assess the feasibility of the TAMBE Device in the treatment of patients with aortic aneurysms involving the visceral branch vessels. A maximum of 10 Subjects will be treated under this Protocol. This clinical study will include up to six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, contrast-enhanced computed tomography (CT) of chest, abdomen and pelvis, creatinine measurement, abdominal ultrasound (optional) at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis implant.

Inclusion criteria

• Aortic aneurysm involving the visceral vessels requiring treatment
• Adequate access for TAMBE Device components
• Appropriate aortic anatomy to receive the TAMBE Device
• Age ≥ 18 years at the time of informed consent signature
• Male or infertile female
• The patient is considered high risk for open repair as deemed by the treating physician
• Capable of complying with protocol requirements, including follow-up
• An Informed Consent Form signed by Subject or legal representative Note: Additional Inclusion Criteria may apply

Exclusion criteria

• Prior aortic surgery
• Ruptured or leaking aortic aneurysm
• Aneurysmal dilatation due to chronic aortic dissection
• Infected aorta
• Mycotic aneurysm
• Life expectancy <2 years
• Myocardial infarction or stroke within 6 weeks of treatment
• Systemic infection which may increase risk of endovascular graft infection
• Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
• Participation in another drug or medical device study within 1 year of study enrollment
• History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of treatment
• Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access
• Known sensitivities or allergies to the device materials
• Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
• Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta
• Renal Insufficiency Note: Additional Exclusion Criteria may apply