Aortic Aneurysm, Abdominal, Aortic Arch Aneurysm, Ascending Aorta Aneurysm
Conditions
Keywords
Aortic Aneurysm, abdominal, Ascending Aorta Aneurysm, Aortic Arch Aneurysm
Brief summary
The purpose of this study is to evaluate visceral function, after endovascular repair of thoracoabdominal aneurysms or ascending/aortic arch aneurysms.
Detailed description
This study will evaluate the effect of endovascular repair of thoracoabdominal aortic aneurysms (Types I-IV) on visceral function or aortic arch aneurysms using custom manufactured and off the shelf stent grafts. Specifically, the device orientation and configuration will be evaluated with respect to renal function. Since detailed CT scan imaging will be performed prior to and after endovascular repair, critical data concerning each branched vessel length, tangential orientation from the aorta, angle of incidence, and diameter can be determined. This information can then be coupled with hemodynamic data obtained from duplex ultrasonography as well as changes in renal volume, estimated glomerular filtration rate (eGFR), and flow characteristics over time. By analyzing the data in this fashion, it may be possible to determine changes in hemodynamics and/or physiologic conditions with respect to branched stent-graft design characteristics. These data may be utilized to enhance current device design and improve patient outcomes. The FDA has approved the use of commercially available devices to be used in conjunction with the investigational device if the Investigator deems this necessary.
Interventions
DEVICEEndovascular repair of thoracoabdominal aortic aneurysm (TAAA) using branched stent graft
Repair of thoracoabdominal aortic aneurysms
DEVICEEndovascular repair of ascending/arch aortic aneurysm using branched stent graft
Repair of ascending/arch aortic aneurysms
Sponsors
University of North Carolina, Chapel Hill
UNC Hospitals
Cook Group Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Cohort 1 (TAAA) Inclusion Criteria: Patients may be included in the study if the patient has at least one of the following and has aortic anatomy appropriate for treatment with the Zenith® p-Branch™, Zenith® t-Branch, or Physician Specified TAAA Endovascular Graft (Custom Manufactured Devices). 1. Aortic Aneurysm Diameter a. TAAA (Type I - IV) (including pararenal subtypes) with orthogonal aortic diameter greater than or equal to 5 cm or b. greater than two times the normal aortic diameter 2. Rapid aortic enlargement (\> than or equal to 5mm in 1 year) 3. Presence of a saccular aneurysm at risk for rupture based on investigators evaluation 4. Iliac artery aneurysm ˃2.2 cm may be treated with the Zenith® Branch Endovascular Graft-Iliac Bifurcation when the iliac artery aneurysm is associated with the qualifying thoracoabdominal aneurysm treated in this study
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in renal function over time (up to two years) after endovascular aortic aneurysm repair various custom stent grafts | Pre-procedure and 1, 6, 12, 18, and 24 months post procedure | Visceral function after endovascular repair of pararenal aneurysms using various custom stent grafts. Specifically, the device orientation and configuration will be evaluated with respect to renal function over time. Critical data concerning each branched vessel from radiological studies coupled with hemodynamic data obtained from renal artery duplex, changes in renal volume, eGFR, and flow characteristics at 1, 6, 12, 18 and 24 months post procedure may make it possible to determine changes in renal function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to morbidity | 30 days and 1 & 2 years post procedure | Morbidity at 30 days, 1 \& 2 years post procedure |
| Time to mortality | 30 days and 1 & 2 years post procedure | Mortality at 30 days, 1 \& 2 years post procedure. |
| Time to loss of stent graft integrity | 30 days and 1 & 2 years post procedure | Evidence on contrast CT angiography of loss of stent graft integrity at 30 days, and one and two years post procedure. |
| Time to migration | 30 days and 1 & 2 years post procedure | Evidence of stent graft migration on abdominal x-rays at 30 days and 1 \& 2 years. |
| Endoleak | 30 days and 1 & 2 years post procedure | Evidence of Endoleak on contrast CT angiography of abdomen 30 days and 1 \& 2 years post procedure. |
| Branch vessel Events | 30 days and 1 & 2 years post procedure | Evidence of branch vessel events on contrast CT angiography and renal duplex 30 days, and 1 \& 2 years post procedure. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMark A Farber, MD
University of North Carolina, Chapel Hill, NC 27599
Outcome results
None listed