Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices
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.
• A patient may be suitable for inclusion in the study if the patient has at least one of the following:
‣ Aortic or aortoiliac aneurysm with diameter ≥5.5 cm
⁃ Aortic or aortoiliac aneurysm with a history of growth ≥1.0 cm per year, or clinical indication for aneurysm repair based on symptoms
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‣ Cannot be treated with a currently available non-modified approved device
⁃ Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device
⁃ At least 18 years of age
⁃ Not pregnant or breastfeeding
⁃ Willing and able to comply with five years of follow-up
⁃ Willing and able to provide informed consent prior to enrollment
⁃ No systemic or local infection that may increase the risk of endovascular graft infection
⁃ 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