This is a single-center study to evaluate the safety and effectiveness of three investigational devices, the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endografts in the treatment of Juxtarenal, Suprarenal, Thoracoabdominal, and Aortic Arch pathologies involving the at least one brachiocephalic artery or visceral vessels. The three investigational devices offer an endovascular approach to treat complex aortic pathologies that cannot be treated with commercially available devices. This customized, endovascular approach has the potential to decrease hospital length of stay, pulmonary complications, and in-hospital mortality.
Described as follows: Juxtarenal, Suprarenal, Thoracoabdominal aortic pathologies involving at least one visceral artery. Aortic Arch pathologies involving the at least one brachiocephalic artery. Once the participant has signed the approved informed consent the following tests will be done to determine final subject eligibility and which device will be used: Juxtarenal, Suprarenal, Thoracoabdominal: Clinical Exam, Blood Tests, CT Scans (with and without contrast), Abdominal Device X-ray, and Angiography. Aortic Arch: Clinical Exam, Neurological Exam, Blood Tests, Echocardiogram, CT Scans (with and without contrast), Chest X-ray, and Angiography. The participants will be followed for 5 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
410
The Cook Custom Aortic Endograft has a variable design such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal aorta, thoracoabdominal aorta, or the aortic arch aorta. Grafts may include a combination of up to 5 fenestrations and/or branches.
The Zenith t-Branch Endovascular Graft is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for proximal fixation of the device. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents.
The Surgeon-Modified Endografts are created in the operating room by modifying a commercially-available Cook Alpha Thoracic Endograft or Cook Zenith Infrarenal Aortic Device such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal or thoracoabdominal aorta. Grafts may include a combination of up to 5 fenestrations and branches.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGRate of major adverse events at 30 days post primary procedure
Time frame: 30 days post primary procedure
Rate of all-cause mortality in peri-operative period
Time frame: Peri-operative
Rate of all-cause mortality at 30 days post primary procedure
Time frame: 30 days post primary procedure
Number of major adverse events at 6 months post primary procedure
Time frame: 6 months post primary procedure
Number of subjects requiring ventilation more than 48 hours in peri-operative period
Time frame: Peri-operative
Average length of ventilation past 48 hours in peri-operative period
Time frame: Peri-operative
Number of subjects requiring reintubation in peri-operative period
Time frame: Peri-operative
Average ICU length of stay in peri-operative period
Time frame: Peri-operative
Number of patients who underwent tracheostomy to treat pulmonary failure at 30 days post primary procedure
Time frame: 30 days post primary procedure
Number of patients who developed postoperative pneumonia at 30 days post primary procedure
Time frame: 30 days post primary procedure
Number of patent treated branch vessels at 30 days post primary procedure
Time frame: 30 days post primary procedure
Number of patients with loss of device integrity at 30 days post primary procedure
Time frame: 30 days post primary procedure
Freedom from reintervention at 30 days post primary procedure
Time frame: 30 days post primary procedure
Number of subjects that achieve treatment success at 12 months post procedure
Treatment success is defined as procedural technical success and patent treated branch vessels at 12 months post procedure, device integrity, and freedom from both reintervention and aortic enlargement ≤5mm as compared to baseline at 12 months post primary procedure. Technical success is defined as successful exclusion of the diseased aortic segment without a clinically significant type I or type III endoleak and patent treated branch vessels at the end of the procedure without the need for unanticipated corrective interventions.
Time frame: 12 months post procedure
Number of major adverse events at 12 months post procedure
Time frame: 12 months post primary procedure
Number of major adverse events at 2 years post primary procedure
Time frame: 2 years post primary procedure
Number of major adverse events at 3 years post primary procedure
Time frame: 3 years post primary procedure
Number of major adverse events at 4 years post primary procedure
Time frame: 4 years post primary procedure
Number of major adverse events at 5 years post primary procedure
Time frame: 5 years post primary procedure
Number of patients who underwent tracheostomy to treat pulmonary failure at 6 months post primary procedure
Time frame: 6 months post primary procedure
Number of patients who underwent tracheostomy to treat pulmonary failure at 12 months post primary procedure
Time frame: 12 months post primary procedure
Number of patients who developed postoperative pneumonia at 6 months post primary procedure
Time frame: 6 months post primary procedure
Number of patients who developed postoperative pneumonia at 12 months post primary procedure
Time frame: 12 months post primary procedure
Number of patent treated branch vessels at 6 months post primary procedure
Time frame: 6 months post primary procedure
Number of patent treated branch vessels at 12 months post primary procedure
Time frame: 12 months post primary procedure
Number of patent treated branch vessels at 2 years post primary procedure
Time frame: 2 years post primary procedure
Number of patent treated branch vessels at 3 years post primary procedure
Time frame: 3 years post primary procedure
Number of patent treated branch vessels at 4 years post primary procedure
Time frame: 4 years post primary procedure
Number of patent treated branch vessels at 5 years post primary procedure
Time frame: 5 years post primary procedure
Number of patients with loss of device integrity at 6 months post primary procedure
Time frame: 6 months post primary procedure
Number of patients with loss of device integrity at 12 months post primary procedure
Time frame: 12 months post primary procedure
Number of patients with loss of device integrity at 2 years post primary procedure
Time frame: 2 years post primary procedure
Number of patients with loss of device integrity at 3 years post primary procedure
Time frame: 3 years post primary procedure
Number of patients with loss of device integrity at 4 years post procedure
Time frame: 4 years post procedure
Number of patients with loss of device integrity at 5 years post primary procedure
Time frame: 5 years post primary procedure
Freedom from reintervention at 6 months post primary procedure
Time frame: 6 months post primary procedure
Freedom from reintervention at 12 months post primary procedure
Time frame: 12 months post primary procedure
Freedom from reintervention at 2 years post primary procedure
Time frame: 2 years post primary procedure
Freedom from reintervention at 3 years post primary procedure
Time frame: 3 years post primary procedure
Freedom from reintervention at 4 years post primary procedure
Time frame: 4 years post primary procedure
Freedom from reintervention at 5 years post primary procedure
Time frame: 5 years post primary procedure
Number of major adverse events at 30 days post primary procedure
Time frame: 30 days post primary procedure
Rate of neurologic morbidity in peri-operative period
Time frame: Peri-operative
Rate of neurologic morbidity at hospital discharge
Time frame: Peri-operative
Rate of neurologic morbidity at 30 days post primary procedure
Time frame: 30 days post primary procedure
Rate of neurologic morbidity at 6 months post primary procedure
Time frame: 6 months post primary procedure
Rate of neurologic morbidity at 12 months post primary procedure
Time frame: 12 months post primary procedure
Rate of neurologic morbidity at 1 year post primary procedure
Time frame: 1 year post primary procedure
Rate of neurologic morbidity at 2 year post primary procedure
Time frame: 2 year post primary procedure
Rate of neurologic morbidity at 3 year post primary procedure
Time frame: 3 year post primary procedure
Rate of neurologic morbidity at 4 year post primary procedure
Time frame: 4 year post primary procedure
Rate of neurologic morbidity at 5 year post primary procedure
Time frame: 5 year post primary procedure
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