Visceral Manifold Study for the repair of thoracoabdominal aortic aneurysms

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Thoracoabdominal Aortic Aneurysms
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who has at least one of the following:
      • an aneurysm with a maximum diameter of > 5.5 cm or 2 times the normal diameter just proximal to the aneurysm.
      • aneurysm with a history of growth > 0.5 cm in 6 months
      • saccular aneurysm deemed at significant risk for rupture
      • symptomatic aneurysm greater than or equal to 4.5 cm
    2. Subjects with axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
    3. Subjects with proximal landing zone for the thoracic bifurcation stent graft as per the protocol
    4. Subjects with iliac artery or aortic distal fixation site, including both native tissue and previously placed graft greater than or equal to 15 mm in length and diameter in the range of 8 – 25 mm
    5. Subjects over the age of 18 and with a life expectancy greater than a year

You may not be eligible for this study if the following are true:

    1. Subjects who are good candidate for and elects for open surgical repair
    2. Subjects who can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
    3. Subjects unwilling to comply with the follow-up schedule
    4. Subjects inability or refusal to give informed consent by patient or legal representative
    5. Subjects are pregnant or breastfeeding
    6. Subjects have a contained rupture
    7. Subjects have a ruptured aneurysm
    8. Subjects with a dissection in the portion of the aorta intended to be treated
    9. Subjects have obstructive stenting of any or all of the visceral vessels
    10. Subjects with poor performance status including two major system failures
    11. Subjects who had prior aneurysm repair that would involve relining of the previously placed graft material requiring placement of the investigational system in a landing zone that expands beyond any limits of the previously placed graft material
    12. Subjects with known sensitivities or allergies to the materials of construction of the devices, including nitinol, polyester, platinum-iridium, polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel.
    13. Subjects with known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
    14. Subjects with uncorrectable coagulopathy
    15. Subjects with body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
    16. Subjects who had major surgical or interventional procedure unrelated to the treatment of the aneurysm planned < 30 days of the endovascular repair
    17. Subjects with an unstable angina
    18. Systemic or local infection that may increase the risk of endovascular graft infection
    19. Subjects with baseline creatinine greater than 2.0 mg/dL
    20. Subjects with history of connective tissue disorders



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