Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA

Summary: The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for the treatment of thoracoabdominal aortic aneurysms (TAAAs). The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith TX2 aortic endograft as compared to previously published results of open surgical replacement of the aneurysmal aorta.

Detailed description: This study is a prospective, single-arm, traditional feasibility study of a physician-modified fenestrated Cook Zenith TX2 aortic endograft base device in adult patients meeting traditional size criteria for open surgical treatment of thoracoabdominal aortic aneurysms. Patients meriting surgical treatment of their aneurysm that also meet inclusion and exclusion criteria will be eligible for enrollment. Patients will be followed for 5 years post procedure. Major adverse events will also be recorded by the Sponsor-Investigator and will be monitored by a locally appointed Data Monitoring Committee, the Institutional Review Board, and the FDA.

Eligibility: Inclusion Criteria:
  1. Must be a man or woman 50 years of age or older by the date of informed consent.
  2. Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that extends no more proximal than the left subclavian artery.
  3. Must have an aneurysm size that meets standard indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta).
  4. Must be considered, in the judgment of the S-I, to be a high risk candidate for open surgical repair.
  5. Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft.
  6. Patient or their legal authorized representative (LAR) must be able to provide informed consent.
  7. Must be able to comply with the five year study assessment schedule of events.
  8. Must have a non-aneurysm-related life expectancy, in the judgment of the S-I, of greater than 2 years.
  Exclusion Criteria:
  1. Aneurysm due to acute or chronic dissection, intramural hematoma, penetrating aortic ulceration, pseudoaneurysm, mycotic aneurysm, or traumatic transection.
  2. Ruptured or acutely symptomatic aortic aneurysm.
  3. Known connective tissue disorder.
  4. Imaging demonstrating any of the following:
  -  Lack of 20 mm non-aneurysmal proximal seal zone (zone 3, or zone 2 with a carotid-subclavian bypass or transposition).
  -  Lack of 15 mm non-aneurysmal distal seal zone(s) (aortic, common iliac, or external iliac).
  -  Branch vessel target (renal, superior mesenteric, or celiac) < 5 mm or > 10 mm in average diameter.
  -  Untreated left subclavian artery stenosis or occlusion.
  -  Untreated unilateral or bilateral hypogastric artery occlusion.
  -  Signs that the inferior mesenteric artery is indispensable.
  -  Have branching, duplication, aneurysm, or untreatable stenosis of the celiac, superior mesenteric artery, or renal arteries that would preclude implantation of the investigational devices.
  5. Known allergy to stainless steel or polyester.
  6. History of anaphylaxis to contrast, with inability to prophylax appropriately.
  7. Have uncorrectable coagulopathy.
  8. Have unstable angina.
  9. Have a body habitus that would inhibit X-ray visualization of the aorta.
  10. Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤30 days of the endovascular repair.
  11. Known to be participating in any other clinical study which may affect performance of this device.
  12. Known or visible pregnancy.
  13. Contraindication to oral antiplatelet therapy.
  14. Prisoners or those on alternative sentencing.
  15. Known systemic infection with potential for endovascular graft infection.
  16. Anticipated need for MRI scanning within 3 months of insertion of investigational product.
  17. Other conditions or comorbidities that, in the opinion of the Sponsor-Investigator, would exclude the patient.

Relevance to patient case: not relevant