Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget thoracic stent graft as an alternative to open surgical repair.

• Subject is > 18 years of age.
• Females subjects must be either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and must have a negative serum pregnancy test at screening.
• Subject is a candidate for endovascular thoracic aortic repair.
• Subject has a TAA that meets one of the following criteria:
• Is diagnosed with a Fusiform Focal TAA >5cm, or
• Is diagnosed with a Fusiform Focal TAA that has a diameter < 5 cm and has exhibited rapid expansion, or
• Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or
• Is diagnosed with a saccular TAA of any size.

Inclusion Criteria:

• Subject is > 18 years of age. Female subjects are either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and have a negative serum pregnancy test at screening.

Subject is a candidate for endovascular thoracic aortic repair.

Subject has a TAA that meets one of the following criteria:

1. Is diagnosed with a Fusiform Focal TAA ≥5cm, or

2. Is diagnosed with a Fusiform Focal TAA that has a diameter ≤ 5 cm and has exhibited rapid expansion, or

3. Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or

4. Is diagnosed with a saccular TAA of any size (where potential for rupture is increased*).

   • Tortuosity and angulation do not exceed 90 degrees.
   • Subject has an arterial access site that allows for the introduction of the stent-graft delivery system.

Exclusion Criteria:

• Subject has a life expectancy < 2 years.
• Subject has a lesion that prevents safe delivery or expansion of the device.
• Subject has concomitant ascending aortic aneurysm.
• Subject has known allergies to any of the device materials.
• Subject has coagulopathy or bleeding disorders that cannot be pre-treated.
• Subject is contraindicated for contrast medium and anticoagulation drugs that cannot be pre-treated.