Visceral (Kidney and Abdominal Organ) Function After Endovascular Aneurysm Repair (EVAR)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
UNC Hospitals
Cook
Information provided by (Responsible Party):
Mark Farber, MD, FACS, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01654133
First received: July 27, 2012
Last updated: May 1, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to evaluate visceral function, after endovascular repair of thoracoabdominal aneurysms.


Condition Intervention
Aortic Aneurysm, Abdominal
Device: Zenith p-Branch endovascular stent graft

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of Visceral Function Following Endovascular Aortic Aneurysm Repair (EVAR) Using Branch Stent-Grafts

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change from baseline in renal function over time (up to two years) after endovascular aortic aneurysm repair using the Zenith p-Branch stent graft [ Time Frame: Pre-procedure and 1, 6, 12, 18, and 24 months post procedure ] [ Designated as safety issue: No ]
    Visceral function after endovascular repair of pararenal aneurysms using the Zenith® p-Branch™ stent graft. 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 [ Time Frame: 30 days and 1 & 2 years post procedure ] [ Designated as safety issue: No ]
    Morbidity at 30 days, 1 & 2 years post procedure

  • Time to mortality [ Time Frame: 30 days and 1 & 2 years post procedure ] [ Designated as safety issue: No ]
    Mortality at 30 days, 1 & 2 years post procedure.

  • Time to loss of stent graft integrity [ Time Frame: 30 days and 1 & 2 years post procedure ] [ Designated as safety issue: No ]
    Evidence on contrast CTA of loss of stent graft integrity at 30 days, and one and two years post procedure.

  • Time to migration [ Time Frame: 30 days and 1 & 2 years post procedure ] [ Designated as safety issue: No ]
    Evidence of stent graft migration on abdominal x-rays at 30 days and 1 & 2 years.

  • Endoleak [ Time Frame: 30 days and 1 & 2 years post procedure ] [ Designated as safety issue: No ]
    Evidence of Endoleak on contrast CTA of abdomen 30 days and 1 & 2 years post procedure.

  • Branch vessel Events [ Time Frame: 30 days and 1 & 2 years post procedure ] [ Designated as safety issue: No ]
    Evidence of branch vessel events on contrast CTA and renal duplex 30 days, and 1 & 2 years post procedure.


Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: enodvascular repair TAAA
Endovascular repair of TAAA using Zenith p-branch endovascular stent graft
Device: Zenith p-Branch endovascular stent graft
Repair of thoracoabdominal aortic aneurysms
Other Name: Endovascular repair of thoracoabdominal aortic aneurysm

Detailed Description:

This study will evaluate the effect of endovascular repair of complex (Type II, III, and IV) thoracoabdominal aortic aneurysms on visceral function using the Zenith p-Branch Endovascular Stent Graft and the Zenith Physician Specified 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, 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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™ Endovascular Graft:

  1. Pararenal or juxtarenal aortic aneurysm with an orthogonal aortic diameter

    1. Greater than or equal to 5 cm, or
    2. 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

Exclusion Criteria:

General Exclusion Criteria

Patients must be excluded from the study if any of the following conditions are true:

  1. Less than 18 years of age
  2. Unwilling to comply with the follow-up schedule
  3. 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:

  1. Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold
  2. History of anaphylactic reaction to contrast material that cannot be adequately premedicated
  3. Leaking, ruptured aneurysm associated with hypotension
  4. Uncorrectable coagulopathy

Anatomical Exclusion Criteria

Patients must be excluded from the study if any of the following conditions are true:

  1. Inadequate femoral/iliac access compatible with the required delivery systems;
  2. Does not have a non-aneurysmal aortic segment proximal to the aneurysm with:

    1. A length of at least 4 mm, i.e. at least 4 mm circumferential wall contact around the limits of scallop
    2. A diameter measured outer wall to outer wall of no greater than 31mm and no less than 21 mm;
    3. An angle less than 60 degrees relative to the centerline of the aneurysm;
    4. An angle less than 45 degrees relative to the supraceliac aorta.
  3. Does not have visceral vessel anatomy compatible with Zenith® p-Branch™, specifically:

    1. Renal vessel origins as measured relative to the SMA compatible with the renal fenestration, i.e. Both renal vessel origins within 7.5mm of the corresponding renal fenestrations;
    2. Celiac vessel origin as measured relative to the SMA compatible with the celiac scallop.
  4. A proximal seal site with unsuitable thrombus/atheroma
  5. Does not have iliac artery fixation sites and anatomy consistent with:

    1. Common iliac artery fixation site diameter, measured outer wall to outer wall on a sectional image (CT) <8.0 mm (prior to deployment)
    2. Iliac artery diameter, measured outer wall to outer wall on a sectional image (CT) >21 mm at distal fixation site
    3. Iliac artery distal fixation site <10 mm in length
    4. Inability to preserve at least one hypogastric artery

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654133

Locations
United States, North Carolina
UNC Heart and Vascular
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
Mark Farber, MD, FACS
UNC Hospitals
Cook
Investigators
Principal Investigator: Mark A Farber, MD University of North Carolina, Chapel Hill, NC 27599
  More Information

No publications provided

Responsible Party: Mark Farber, MD, FACS, Director of Aortic Disease Center, Associate Professor Surgery & Radiology, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01654133     History of Changes
Other Study ID Numbers: 12-0062
Study First Received: July 27, 2012
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Aortic Aneurysm, abdominal

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014