Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Study Update as of 11/16/2018;95 subjects successfully have been implanted with the Zenith
t-Branch Device to date and recruitment is ongoing.

Inclusion Criteria

The patient must have one of the following:

1. Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic
aneurysms (fusiform or saccular):≥55mm in diameter in a male or ≥50mm in diameter in a
female, or

2. Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or

3. Penetrating ulcers: ≥20mm in depth or

4. Chronic type B aortic dissections: ≥50mm total aortic diameter or

5. Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size.

Additional criteria for LP material

• Iliofemoral access vessels <8mm or with significant atherosclerotic occlusive disease
that would require an iliac conduit as determined by the Principle Investigator

Exclusion Criteria

General Criteria

1. Life-expectancy less than 12 months

2. Refusal to receive blood products

3. Age <18 years

4. Pregnant or breastfeeding or planning on becoming pregnant within 60 months

5. Unwilling to comply with the follow-up schedule

6. Inability or refusal to give informed consent by subject and/or Legally Authorized
Representative (LAR); should one be utilized

Medical Criteria

1. Uncontrolled systemic infection

2. Untreatable malignancy

3. Uncontrollable anaphylaxis to iodinated contrast

4. Known allergy(ies) to device materials

Anatomic Criteria

1. Any pathology of mycotic origin

2. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)

3. Inability to insert the Zenith® t-Branch device through iliofemoral approach

4. Proximal and distal neck angle less than 90 degrees relative to the long axis of the
aneurysm

5. Proximal landing zone length <25mm to allow secure fixation and seal

6. Proximal landing zone diameter of <24mm or >42mm

7. Distal landing zone length <25mm in the abdominal aorta or <20mm in the iliac arteries

8. Distal landing zone diameter of <14mm or >30mm in the abdominal aorta, or <7mm or
>28mm in the iliac arteries