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RecruitingNCT02043691Updated Jan 6, 2026

Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft in Treating Aortic Pathologies

An interventional study of Cook Custom Aortic Endograft and Zenith t-Branch Endovascular Graft in Juxtarenal Aortic Aneurysm, Suprarenal Aortic Aneurysm and Thoracoabdominal Aortic Aneurysm, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2014; still recruiting 12 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
410
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Juxtarenal Aortic Aneurysm
  • Suprarenal Aortic Aneurysm
  • Thoracoabdominal Aortic Aneurysm
  • Penetrating Aortic Ulcer
  • Aortic Arch Aneurysm
  • Aortic Dissection

Keywords

  • Endovascular
  • Aortic
  • Aneurysm
  • Thoracoabdominal
  • Juxtarenal
  • Suprarenal
  • Endograft
  • Fenestrated
  • Branched
  • Complex
  • Abdominal
  • Thoracic
  • Stent
  • Stentgraft
  • Arch
  • Ascending
  • Dissection
  • Descending
03

In context

Aortic Aneurysm, Thoracoabdominal

63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.

This study's planned enrollment of 410 is above the median of 80 across 41 interventional studies indexed under Aortic Aneurysm, Thoracoabdominal.

Browse Aortic Aneurysm, Thoracoabdominal studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

Browse University of Alabama at Birmingham studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Juxtarenal, suprarenal, and thoracoabdominal aortic pathology as follows in hemodynamically stable patients:

    1. Intact or contained ruptured aortic or aortoiliac aneurysms (atherosclerotic/degenerative or saccular) involving or in close approximation to the visceral segment of the aorta.

      1. Diameter > 5.5 cm if asymptomatic, or 5.0 cm with enlargement of > 0.5 cm in 6 months.
      2. History of growth > 0.5 cm per year
      3. Any size if ruptured or symptomatic

    2. Penetrating aortic ulcer (PAU)

      1. > 2.0 cm in depth
      2. Any size if contained ruptured or symptomatic

    3. Subacute (>14 days) or chronic (>20 days) aortic dissection with aneurysmal degeneration with at least one of the following:

      1. Total aortic diameter > 5.5 cm if asymptomatic
      2. Total aortic diameter > 4.5 cm if symptomatic
      3. Total aortic diameter > 5.0 cm and history of growth > 0.5 cm in 6 months

  • Aortic Arch pathology:

    1. Aneurysm, Ascending thoracic aortic pseudoaneurysm, Type A thoracic aortic dissection, Retrograde type A thoracic aortic dissection between the Sinus of Valsalva and the innominate artery orifice (without involvement of the Aortic Valve), or Ascending penetrating aortic ulcer with and without intramural hematoma
    2. Suitable iliac artery and brachial artery access
    3. Absence of severe landing zone (> 90 degree) angulation that would preclude necessary device delivery/seal/fixation.
    4. Suitable iliac artery access to accommodate device delivery system.

    5. Target arteries for arch branches:

      1. \< 24 mm diameter
      2. Adequate landing zone length to obtain proximal and distal seal.
      3. Free from dissection precluding adequate seal in distal landing zone of branch stent and severe tortuosity/thrombus/calcification.

  • Aortic Arch Aneurysm

    1. Proximal aortic fixation zone:

      1. Native aorta or surgical graft
      2. Diameter: 20 - 42 mm
    2. Proximal neck length > 20 mm
    3. Must occur distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion.

    4. Distal aortic fixation zone:

      1. Native aorta or surgical graft
      2. Diameter: 20 - 44 mm
    5. Distal neck length > 20 mm. However, if dissection, distal graft may land in dissected aorta.

    6. Supra-aortic trunk (brachiocephalic) vessels (Any combination of arteries may be used for repair) A. Innominate artery

      1. Native vessel or surgical graft
      2. Diameter: 8 - 22 mm
      3. Length of sealing zone > 10 mm
      4. Acceptable tortuosity B. Left (or right) common carotid artery

      <!-- -->

      1. Native vessel or surgical graft
      2. Diameter 5 - 20 mm
      3. Length of sealing zone > 10 mm C. Left (or right) subclavian artery

      <!-- -->

      1. Native vessel or surgical graft
      2. Diameter 5 - 20 mm
      3. Length of sealing zone > 10 mm

  • Aortic Dissection

    1. Access into the true lumen from the groin and at least one supra-aortic trunk vessel.
    2. Seal zone in the target aorta (or surgical graft) that is proximal to the primary dissection, such that a stent-graft would be anticipated to seal off the dissection lumen.
    3. Seal zone in the target supra-aortic trunk vessels that is distal to the dissection, anticipated to seal off the dissection lumen or surgically created.
    4. True lumen size large enough to deploy the device and still gain access into the target branch.

General Exclusion Criteria:

  • Less than 18 years of age
  • less than 12 months based on the surgeon's assessment
  • Pregnant or breastfeeding or planning on becoming pregnant within 60 months
  • Inability or refusal to give
  • Unwilling or unable to comply with the follow-up schedule
  • Less than 30 days beyond primary endpoint for other investigative drug or device study

Medical Exclusion Criteria:

  • Known allergy to the device components (i.e. stainless steel, polyester, solder, gold, or nitinol)
  • History of anaphylactic reaction to contrast material that cannot be adequately premedicated
  • Systemic or local infection that may increase the risk of endovascular graft infection.
  • Baseline \< 30 mL/min (calculated by the Modification of Diet in Renal Disease formula) and not on hemo- or peritoneal dialysis. If the patient is currently on dialysis, or is currently planning on initiating dialysis, then they may undergo repair.
  • Body habitus that would inhibit X-ray visualization of the aorta.
  • Major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair.
  • Unstable angina, defined as a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina.
  • Irreversible coagulopathy

Anatomical Exclusion Criteria:

  • Aortic transection due to acute trauma.
  • Infectious ("mycotic") etiology of the aortic disease.
  • Significant occlusive disease or tortuosity precluding delivery of the device components.
  • Juxtarenal, Suprarenal, and Thoracoabdominal:
  • Proximal Landing zone \< 20 mm in length. The proximal landing zone can be within zones 2 through 8, with least 20 mm of proximal seal and fixation in aorta or Dacron.
  • Proximal neck, defined as the thoracic aorta distal to the native left carotid artery, measured outer wall to outer wall on a sectional image (CT) > 41 mm in diameter or \< 18 mm in diameter
  • Distal landing zone \< 20 mm in length if the landing zone is in the aorta, or \< 20 mm if the landing zone is in the iliac arteries or in Dacron (in the event the patient has had a previous or concomitant aortic or aorto-iliac reconstruction).
  • Untreatable branch vessel stenosis.
  • Anatomy that would not allow maintenance of at least one patent hypogastric artery.
  • Signs that the inferior mesenteric artery (IMA) is indispensable (i.e. angiographic visualization or a large IMA, filling of superior mesenteric artery (SMA) via collaterals, stenosis of celiac or SMA or oblique views) and the indispensable IMA is not amenable to treatment with a graft branch or fenestration.
  • Branching, duplication, aneurysm or untreatable stenosis of the celiac, SMA or renal arteries that would preclude implantation of the devices.
  • Aortic arch:
  • Proximal neck > 44 mm or \< 28 mm in diameter
  • Inadequate landing zone to allow adequate distal seal of exclusion of false lumen perfusion in dissection.
  • Untreatable branch vessel stenosis.
  • Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access.
  • Patients qualifying for an industry-sponsored study allowing for a similar repair will be enrolled in the industry-sponsored study.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
410 participants (estimated)

Study arms

  • Experimental
    Cook Custom Aortic Endograft

    Participants will receive the following: (Juxtarenal, Suprarenal, Thoracoabdominal) Clinical Exam, Blood Tests, CT Scans (with and without contrast) or Ultrasound, 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. These tests will aid in the design of the Cook Custom Aortic Endograft. 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.

    Device: Cook Custom Aortic Endograft

  • Experimental
    Zenith t-Branch Endovascular Graft

    Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast) or Ultrasound, Abdominal Device X-ray, and Angiography. These tests will aid in the sizing of the the Zenith t-Branch Endovascular Graft. 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.

    Device: Zenith t-Branch Endovascular Graft

  • Experimental
    Surgeon-Modified Endograft

    Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast) or Ultrasound, Abdominal Device X-ray, and Angiography. These tests will aid in the design of the Surgeon-Modified Endografts. These will be 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.

    Device: Surgeon-Modified Endograft

Interventions

  • DeviceCook Custom Aortic Endograft

    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.

  • DeviceZenith t-Branch Endovascular Graft

    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.

  • DeviceSurgeon-Modified Endograft

    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.

06

What researchers measure

Primary outcomes

  1. Rate of major adverse events at 30 days post primary procedure

    Time frame: 30 days post primary procedure

Secondary outcomes

  1. Rate of all-cause mortality in peri-operative period

    Time frame: Peri-operative

  2. Rate of all-cause mortality at 30 days post primary procedure

    Time frame: 30 days post primary procedure

  3. Number of major adverse events at 6 months post primary procedure

    Time frame: 6 months post primary procedure

  4. Number of subjects requiring ventilation more than 48 hours in peri-operative period

    Time frame: Peri-operative

  5. Average length of ventilation past 48 hours in peri-operative period

    Time frame: Peri-operative

  6. Number of subjects requiring reintubation in peri-operative period

    Time frame: Peri-operative

  7. Average ICU length of stay in peri-operative period

    Time frame: Peri-operative

  8. Number of patients who underwent tracheostomy to treat pulmonary failure at 30 days post primary procedure

    Time frame: 30 days post primary procedure

  9. Number of patients who developed postoperative pneumonia at 30 days post primary procedure

    Time frame: 30 days post primary procedure

  10. Number of patent treated branch vessels at 30 days post primary procedure

    Time frame: 30 days post primary procedure

  11. Number of patients with loss of device integrity at 30 days post primary procedure

    Time frame: 30 days post primary procedure

  12. Freedom from reintervention at 30 days post primary procedure

    Time frame: 30 days post primary procedure

  13. 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

  14. Number of major adverse events at 12 months post procedure

    Time frame: 12 months post primary procedure

  15. Number of major adverse events at 2 years post primary procedure

    Time frame: 2 years post primary procedure

  16. Number of major adverse events at 3 years post primary procedure

    Time frame: 3 years post primary procedure

  17. Number of major adverse events at 4 years post primary procedure

    Time frame: 4 years post primary procedure

  18. Number of major adverse events at 5 years post primary procedure

    Time frame: 5 years post primary procedure

  19. Number of patients who underwent tracheostomy to treat pulmonary failure at 6 months post primary procedure

    Time frame: 6 months post primary procedure

  20. Number of patients who underwent tracheostomy to treat pulmonary failure at 12 months post primary procedure

    Time frame: 12 months post primary procedure

  21. Number of patients who developed postoperative pneumonia at 6 months post primary procedure

    Time frame: 6 months post primary procedure

  22. Number of patients who developed postoperative pneumonia at 12 months post primary procedure

    Time frame: 12 months post primary procedure

  23. Number of patent treated branch vessels at 6 months post primary procedure

    Time frame: 6 months post primary procedure

  24. Number of patent treated branch vessels at 12 months post primary procedure

    Time frame: 12 months post primary procedure

  25. Number of patent treated branch vessels at 2 years post primary procedure

    Time frame: 2 years post primary procedure

  26. Number of patent treated branch vessels at 3 years post primary procedure

    Time frame: 3 years post primary procedure

  27. Number of patent treated branch vessels at 4 years post primary procedure

    Time frame: 4 years post primary procedure

  28. Number of patent treated branch vessels at 5 years post primary procedure

    Time frame: 5 years post primary procedure

  29. Number of patients with loss of device integrity at 6 months post primary procedure

    Time frame: 6 months post primary procedure

  30. Number of patients with loss of device integrity at 12 months post primary procedure

    Time frame: 12 months post primary procedure

  31. Number of patients with loss of device integrity at 2 years post primary procedure

    Time frame: 2 years post primary procedure

  32. Number of patients with loss of device integrity at 3 years post primary procedure

    Time frame: 3 years post primary procedure

  33. Number of patients with loss of device integrity at 4 years post procedure

    Time frame: 4 years post procedure

  34. Number of patients with loss of device integrity at 5 years post primary procedure

    Time frame: 5 years post primary procedure

  35. Freedom from reintervention at 6 months post primary procedure

    Time frame: 6 months post primary procedure

  36. Freedom from reintervention at 12 months post primary procedure

    Time frame: 12 months post primary procedure

  37. Freedom from reintervention at 2 years post primary procedure

    Time frame: 2 years post primary procedure

  38. Freedom from reintervention at 3 years post primary procedure

    Time frame: 3 years post primary procedure

  39. Freedom from reintervention at 4 years post primary procedure

    Time frame: 4 years post primary procedure

  40. Freedom from reintervention at 5 years post primary procedure

    Time frame: 5 years post primary procedure

  41. Number of major adverse events at 30 days post primary procedure

    Time frame: 30 days post primary procedure

  42. Rate of neurologic morbidity in peri-operative period

    Time frame: Peri-operative

  43. Rate of neurologic morbidity at hospital discharge

    Time frame: Peri-operative

  44. Rate of neurologic morbidity at 30 days post primary procedure

    Time frame: 30 days post primary procedure

  45. Rate of neurologic morbidity at 6 months post primary procedure

    Time frame: 6 months post primary procedure

  46. Rate of neurologic morbidity at 12 months post primary procedure

    Time frame: 12 months post primary procedure

  47. Rate of neurologic morbidity at 1 year post primary procedure

    Time frame: 1 year post primary procedure

  48. Rate of neurologic morbidity at 2 year post primary procedure

    Time frame: 2 year post primary procedure

  49. Rate of neurologic morbidity at 3 year post primary procedure

    Time frame: 3 year post primary procedure

  50. Rate of neurologic morbidity at 4 year post primary procedure

    Time frame: 4 year post primary procedure

  51. Rate of neurologic morbidity at 5 year post primary procedure

    Time frame: 5 year post primary procedure

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Mesnard T, Huang Y, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Parodi FE, Gasper WJ, Beck AW, Sweet MP, Zetterval SL, Lee A, Oderich GS; United States Aortic Research Consortium. Multicenter Prospective Evaluation of Patient Radiation Exposure During Fenestrated-branched Endovascular Aortic Repair: A Ten-year Experience. Ann Surg. 2026 Jul 1;284(1):184-193. doi: 10.1097/SLA.0000000000006676. Epub 2025 Feb 18. PubMed 39963789 ↗
  • Oderich GS, Huang Y, Harmsen WS, Tenorio ER, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Gasper WJ, Beck AW, Sweet MP, Lee WA; United States Aortic Research Consortium. Early and Late Aortic-Related Mortality and Rupture After Fenestrated-Branched Endovascular Aortic Repair of Thoracoabdominal Aortic Aneurysms: A Prospective Multicenter Cohort Study. Circulation. 2024 Oct 22;150(17):1343-1353. doi: 10.1161/CIRCULATIONAHA.123.068234. Epub 2024 Jul 11. PubMed 38989575 ↗
  • Finnesgard EJ, Beck AW, Eagleton MJ, Farber MA, Gasper WJ, Lee WA, Oderich GS, Schneider DB, Sweet MP, Timaran CH, Simons JP, Schanzer A; United States Aortic Research Consortium. Severity of acute kidney injury is associated with decreased survival after fenestrated and branched endovascular aortic aneurysm repair. J Vasc Surg. 2023 Oct;78(4):892-901. doi: 10.1016/j.jvs.2023.05.034. Epub 2023 Jun 16. PubMed 37330702 ↗
  • Aucoin VJ, Motyl CM, Novak Z, Eagleton MJ, Farber MA, Gasper W, Oderich GS, Mendes B, Schanzer A, Tenorio E, Timaran CH, Schneider DB, Sweet MP, Zettervall SL, Beck AW; U.S. Aortic Research Consortium. Predictors and outcomes of spinal cord injury following complex branched/fenestrated endovascular aortic repair in the US Aortic Research Consortium. J Vasc Surg. 2023 Jun;77(6):1578-1587. doi: 10.1016/j.jvs.2023.01.205. Epub 2023 Apr 13. PubMed 37059239 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02043691
Lead sponsor
University of Alabama at Birmingham
Collaborators
Cook Group Incorporated
Responsible party
Adam W Beck (Principal Investigator, University of Alabama at Birmingham) — Principal investigator
First posted
Jan 23, 2014
Start date
Jun 2014
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Jan 6, 2026

Study contacts

Adam W Beck, MD
Contact
awbeck@uabmc.edu
Rebecca St John
Contact
rstjohn@uabmc.edu
Adam W Beck, MD
principal investigator · University of Alabama at Bimingham

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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