ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial

A Phase I Feasibility Study of the TAArget Thoracic Stent Graft for the Treatment of Aneurysms in the Descending Thoracic Aorta

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.