Visceral (Kidney and Abdominal Organ) Function After Fenestrated and Branched Endovascular Aneurysm Repair (FEVAR/BEVAR) of Thoracoabdominal Aortic Aneurysms
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate visceral function, after endovascular repair of thoracoabdominal aneurysms.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study will evaluate the effect of endovascular repair of thoracoabdominal aortic aneurysms (Types I-IV) on visceral function 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: endovascular repair TAAA Endovascular repair of thoracoabdominal aortic aneurysm (TAAA) using Branched stent grafts |
Device: Endovascular repair of thoracoabdominal aortic aneurysm (TAAA) using branched stent graft
Repair of thoracoabdominal aortic aneurysms
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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).
-
Aortic Aneurysm Diameter
-
TAAA (Type I - IV) (including pararenal subtypes) with orthogonal aortic diameter greater than or equal to 5 cm or
-
greater than two times the normal aortic diameter
-
Rapid aortic enlargement (> than or equal to 5mm in 1 year)
-
Presence of a saccular aneurysm at risk for rupture based on investigators evaluation
-
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 Exclusion Criteria
Patients must be excluded from the study if any of the following conditions are true:
-
Less than 18 years of age
-
Unwilling to comply with the follow-up schedule
-
Inability or refusal to give informed consent
Medical Exclusion Criteria
Patients must be excluded from the study if any of the following conditions are true:
-
Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold
-
History of anaphylactic reaction to contrast material that cannot be adequately premedicated
-
Leaking, ruptured aneurysm associated with hypotension
-
Uncorrectable coagulopathy
Anatomical Exclusion Criteria
Patients must be excluded from the study if any of the following conditions are true:
-
Inadequate femoral/iliac access compatible with the required delivery systems;
-
Does not have a non-aneurysmal aortic segment proximal to the aneurysm with:
-
A length of at least 4 mm, i.e. at least 4 mm circumferential wall contact around the limits of scallop
-
A diameter measured outer wall to outer wall of no greater than 31mm and no less than 21 mm;
-
An angle less than 60 degrees relative to the centerline of the aneurysm;
-
An angle less than 45 degrees relative to the supraceliac aorta.
-
Does not have visceral vessel anatomy compatible with Zenith® p-Branch™, specifically:
-
Renal vessel origins as measured relative to the superior mesenteric artery (SMA) compatible with the renal fenestration, i.e. Both renal vessel origins within 7.5mm of the corresponding renal fenestrations;
-
Celiac vessel origin as measured relative to the superior mesenteric artery (SMA) compatible with the celiac scallop.
-
A proximal seal site with unsuitable thrombus/atheroma
-
Does not have iliac artery fixation sites and anatomy consistent with:
-
Common iliac artery fixation site diameter, measured outer wall to outer wall on a sectional image (CT) <8.0 mm (prior to deployment)
-
Iliac artery diameter, measured outer wall to outer wall on a sectional image (CT) >21 mm at distal fixation site
-
Iliac artery distal fixation site <10 mm in length
-
Inability to preserve at least one hypogastric artery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UNC Heart and Vascular | Chapel Hill | North Carolina | United States | 27599 |
Sponsors and Collaborators
- University of North Carolina, Chapel Hill
- UNC Hospitals
- Cook Group Incorporated
Investigators
- Principal Investigator: Mark A Farber, MD, University of North Carolina, Chapel Hill, NC 27599
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 12-0644