Safety and Efficacy of the SETA LATECBA Stent Graft for EVAR in Subjects With AAA

This is an interventional treatment trial for Abdominal Aortic Aneurysm Read More

Inclusion Criteria:

• Male and female adults older than 18 years old, willing to cooperate with the study. No other demographic restriction.
• Initial diagnosis of AAA according to the standard of care criteria following the guidance Clinical Practice Guidelines for Endovascular Abdominal Aortic Aneurysm Repair
• Medical history: Complete history of previous, present and concomitant conditions, and current treatments for other conditions Signed informed consent. If the patient cannot consent, the subject's legally acceptable representative should consent

Diagnosis of Abdominal Aortic Aneurysm (AAA) according to the following criteria:

1. Diagnosis of an abdominal aortic aneurysm with a diameter ≥ 5.0 cm for males or ≥ 4.5 cm for females.
2. Aneurysm diameter with a growth rate ≥ 0.5 cm/ 6 months
3. The juxtarenal neck length between 1 mm and 10 mm
4. Neck diameter ≥16 to ≤ 26 mm
5. Suprarenal aorta diameter ≥ infrarenal aorta diameter
6. Proximal neck angulated ≤ 60 degrees relative to the long axis of the aneurysm
7. Immediate suprarenal aorta angulated ≤ 60 degrees relative to the immediate infrarenal neck.
8. Common iliac diameter 8 to 20 mm.
9. Common iliac length 25 mm
10. Common iliac angle 60 degrees
11. Not eligible for other standard EVAR surgical procedure

Exclusion Criteria:

• General Exclusion Criteria

  1. Life expectancy less than 2 years
  2. Pregnant or breastfeeding or planning on becoming pregnant within 60 months
  3. Included in another investigative drug or device study/studies or planning to do it within the following 24 months

Medical Exclusion Criteria

1. Previous treatment of AAA
2. Known allergy to polyester, stainless steel, nitinol and or gold, teflon, nylon,
3. Known anaphylactic reaction to contrast media.
4. Any type coagulopathy untreated.
5. Genetic connective tissue diseases, such as Marfan or Ehlers-Danlos syndromes
6. Planned interventional or surgical procedure within 30 days before or after AAA repair.
7. Renal dysfunction: creatinine level over 1.7 mg/dl

8. Systemic infection or fever over 38°C

   AAA Anatomy Exclusion Criteria

9. Significant occlusive disease, tortuosity, or calcification.

i) Significant thrombus in the fixation sites. j) Fungal aneurysm k) Leaking/ruptured or symptomatic aneurysm. l) Traumatic aneurysm. m) Concurrent aneurysm of the thoracic aorta. n) One or both renal arteries coming from the aneurysmal sac. o) Proximal neck diameter, measured outer wall to outer wall on a sectional image (CTA) > 26 mm in diameter or < 16 mm in diameter p) Proximal neck angle > 60 degrees relative to the long axis of the aneurysm q) Immediate suprarenal aorta angle > 60 degrees relative to the immediate infrarenal neck.

r) Immediate suprarenal aorta angle > 60 degrees relative to the immediate infrarenal neck s) Aortic diameter, measured inner wall to inner wall on a sectional image (CTA) < 15 mm at the bifurcation t) Iliac/femoral anatomy that is unsuitable for access. u) Iliac artery diameter, measured outer wall to outer Wall on a sectional image (CTA) > 20 mm or < 8 mm at distal fixation site.

v) Iliac artery distal fixation site < 10 mm in length. w) Indispensable inferior mesenteric artery (IMA)