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

NCT02043691 | Recruiting

• 1 other identifier: 201400001
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Rate of major adverse events at 30 days post primary procedure

  30 days post primary procedure

Secondary Outcomes (51)

• Rate of all-cause mortality in peri-operative period

  Peri-operative

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

  30 days post primary procedure

• Number of major adverse events at 6 months post primary procedure

  6 months post primary procedure

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

  Peri-operative

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

  Peri-operative

Study Arms (3)

Cook Custom Aortic Endograft

EXPERIMENTAL

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

Zenith t-Branch Endovascular Graft

EXPERIMENTAL

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

Surgeon-Modified Endograft

EXPERIMENTAL

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

Cook Custom Aortic Endograft DEVICE

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.

Cook Custom Aortic Endograft

Zenith t-Branch Endovascular Graft DEVICE

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.

Zenith t-Branch Endovascular Graft

Surgeon-Modified Endograft DEVICE

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.

Surgeon-Modified Endograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Juxtarenal, suprarenal, and thoracoabdominal aortic pathology as follows in hemodynamically stable patients:
• Intact or contained ruptured aortic or aortoiliac aneurysms (atherosclerotic/degenerative or saccular) involving or in close approximation to the visceral segment of the aorta.
• Diameter \> 5.5 cm if asymptomatic, or 5.0 cm with enlargement of \> 0.5 cm in 6 months.
• History of growth \> 0.5 cm per year
• Any size if ruptured or symptomatic
• Penetrating aortic ulcer (PAU)
• \> 2.0 cm in depth
• Any size if contained ruptured or symptomatic
• Subacute (\>14 days) or chronic (\>20 days) aortic dissection with aneurysmal degeneration with at least one of the following:
• Total aortic diameter \> 5.5 cm if asymptomatic
• Total aortic diameter \> 4.5 cm if symptomatic
• Total aortic diameter \> 5.0 cm and history of growth \> 0.5 cm in 6 months
• Aortic Arch pathology:
• 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
• Suitable iliac artery and brachial artery access

You may not qualify if:

• Less than 18 years of age
• Life expectancy 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 informed consent
• Unwilling or unable to comply with the follow-up schedule
• Less than 30 days beyond primary endpoint for other investigative drug or device study
• 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 eGFR \< 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
• Aortic transection due to acute trauma.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Cook Group Incorporated: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Related Publications (4)

• 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. 2025 Feb 18. doi: 10.1097/SLA.0000000000006676. Online ahead of print.

  PMID: 39963789 DERIVED

• 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.

  PMID: 38989575 DERIVED

• 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.

  PMID: 37330702 DERIVED

• 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.

  PMID: 37059239 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal; Penetrating Atherosclerotic Ulcer; Aneurysm, Aortic Arch; Aortic Dissection; Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Acute Aortic Syndrome; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Aneurysm, Thoracic; Dissection, Blood Vessel

Study Officials

• Adam W Beck, MD

  University of Alabama at Bimingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam W Beck, MD

CONTACT

awbeck@uabmc.edu

Rebecca St John

CONTACT

rstjohn@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 23, 2014
• Study Start: June 1, 2014
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

US (1)