Physician-Modified Endografts for Complex Aortic Aneurysms and Thoracoabdominal Aneurysm Repair in High-Risk Patients

This single-arm FDA-monitored protocol intends to broaden endovascular device applicability using physician-modifications in patients who A) Have anatomical conditions not amenable to endovascular repair using currently marketed grafts in the United States. B) Are at high risk for open surgical repair. C) Are high-risk subjects with previously placed endovascular devices and have developed failure of their previous devices. The use of physician-modified endografts aims to shift the seal zone proximally above the celiac artery in order to treat their complex or thoracoabdominal aneurysms in a minimally invasive fashion. These patients are considered too high risk to survive open surgical repair and do not meet anatomic criteria for the Gore Thoracoabdominal Multi Branch Endoprosthesis, which is currently the only FDA approved device in the US to treat these aneurysms. The primary objective is to evaluate safety and effective of physician modified endografts in the treatment of thorax-abdominal aneurysms and complex aortic aneurysms. For primary safety endpoints, mortality and major adverse events (MAE) will be analyzed at 30 days or in hospitalization (if this exceeds 30 days). Primary endpoints include the following: 1. Mortality related to primary aortic disease 2. Aneurysm rupture 3. All cause mortality For primary effectiveness endpoints, treatment success will be analyzed as the proportion of patients to achieve treatment success at 12 months. Treatment success is defin…

This description comes directly from the study's public registry record.

Andrea Martinez  ·  713-798-6835  ·  andrea.martinez@bcm.edu

Steven Maximus, MD  ·  951-206-9835  ·  steven.maximus@bcm.edu

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