The purpose of this study is to assess the role endovascular therapy to treat aortic disease involving the ascending aorta, the aortic arch, and the visceral segment of the aorta (or thoracoabdominal aorta)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Anatomic Inclusion Criteria
✓. Focal aneurysm in ascending aorta
✓. Pseudoaneurysms and/or dissections that are distal to the sinotubular junction.
✓. A thoracoabdominal aortic aneurysm ≥ 5.0 cm in women and ≥ 5.5 cm in men
✓. Have morphology or growth suggestive of immanent rupture
✓. Proximal Fixation:
✓. \>15 mm aortic length distal to a patent coronary artery or coronary artery bypass that are considered patent and necessary for proper cardiac perfusion.
✓. Aortic diameter at the sinotubular junction \>20 mm and ≤ 38mm
Exclusion criteria
✕. Patient can be treated in accordance with the instructions for use with a commercially marketed endovascular prosthesis
✕. Patient qualifies for treatment of thoracoabdominal aortic repair under an industry-sponsored clinical trial, open to enrollment at the Massachusetts General Hospital \& Brigham and Women's Hospital
✕. Pregnancy
✕. History of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately
✕. Known sensitivity or allergy to materials of construction of the device (including the materials of the LP device).
✕. Body habitus that would inhibit X-ray visualization of the aorta
✕. Subject had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned \<30 days from the endovascular repair