Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices

Summary

The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysms and aortic arch aneurysms who (1) have anatomy not suitable for endovascular repair using grafts currently marketed in the United States,(2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.

Eligibility

Inclusion Criteria:

* A patient may be suitable for inclusion in the study if the patient has at least one of the following:

  1. Aortic or aortoiliac aneurysm with diameter ≥5.5 cm
  2. Aortic or aortoiliac aneurysm with a history of growth ≥1.0 cm per year, or clinical indication for aneurysm repair based on symptoms

     General Inclusion Criteria

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  1. Cannot be treated with a currently available non-modified approved device
  2. Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device
  3. At least 18 years of age
  4. Not pregnant or breastfeeding
  5. Willing and able to comply with five years of follow-up
  6. Willing and able to provide informed consent prior to enrollment
  7. No systemic or local infection that may increase the risk of endovascular graft infection
  8. High risk for open surgical repair based on any of the factors below:

     a. Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta) iii. Previous aortic surgery b. Physiologic i. ASA Category III or higher ii. Age \>70 years iii. Previous myocardial infarction, coronary artery disease, or coronary artery stent iv. Coronary stress test with a reversible perfusion defect v. Congestive heart failure vi. COPD

     Exclusion Criteria:
* Exclusion Criteria Medical Exclusion Criteria

  1. Cultural objection to receipt of blood or blood products
  2. Allergy or sensitivity to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol
  3. Anaphylactic reaction to contrast that cannot be adequately pre-medicated
  4. Uncorrectable coagulopathy
  5. Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
  6. Patient has active malignancy with life expectancy of less than 2 years
  7. Patient has life expectancy less than two years

Anatomical Exclusion Criteria

1. Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access
2. Proximal neck length ≤25 mm
3. Proximal neck, measured outer wall to outer wall on a sectional image (CT)

   1. For use of Zenith Flex: diameter \>32 mm or \<18 mm
   2. For use of Zenith TX2: diameter \>38 mm or \<24 mm (for proximal and distal neck diameter)
4. Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm
5. Proximal neck diameter change over the length of the proximal seal zone \>4 mm
6. Proximal seal site with a circumferential thrombus/atheroma
7. Iliac artery diameter, measured inner wall to inner wall on a sectional image (CT) \<7.0 mm at any point along access length (prior to deployment)
8. Ipsilateral iliac artery fixation site diameter, measured inner wall on a sectional image (CT) \>21 mm at distal fixation site
9. Iliac artery distal fixation site \<10 mm in length
10. Non-bifurcated segment of any artery to be stented \< 15 mm in length
11. Artery to be stented with a maximum diameter \<3 mm or \>10 mm at the vessel ostium
12. Inability to maintain at least one patent hypogastric artery

Conditions9

Locations1 site

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