Evaluation of Spinal Cord Ischemia and Mortality and Morbidity After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysm Using Surgeon-Modified Endografts
Konstantinos Dean Arnaoutakis, MD
Summary
The primary objective is to evaluate the safety and effectiveness of surgeon modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology in patients who are not candidate for traditional open repair due to comorbid issues and their anatomy is not amenable to commercially available endografts.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Male or female, aged ≥18 years 3. Expected survival beyond 1 year following successful aneurysm repair 4. Anatomy that would require coverage of the celiac artery, superior mesenteric artery (SMA), and/or renal arteries if conventional, FDA-approved endograft were implanted to obtain adequate sealing zone length 5. Aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection 6. Adequate proximal zone of fixation 7. Adequate distal zone of fixation 8. No more than 5 non-aneurysmal visceral (…
Interventions
- DevicePMEG
All devices that will be modified in this study protocol are commercially available in the United States. The commercially available endografts will be used to construct a fenestrated/branched device for this intervention.
Locations (2)
- Tampa General HospitalTampa, Florida
- University of South Florida - South Tampa CampusTampa, Florida