Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft in Treating Aortic Pathologies
Recruiting now · Not applicable
Conditions studied: Juxtarenal Aortic Aneurysm, Suprarenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Penetrating Aortic Ulcer, Aortic Arch Aneurysm, Aortic Dissection
In brief
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.
Key facts
- Study ID
- NCT02043691
- Run by
- University of Alabama at Birmingham
- People needed
- 410
- Starts
- 2014-06-01
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-01-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- Absence of severe landing zone (> 90 degree) angulation that would preclude necessary device delivery/seal/fixation.
- Suitable iliac artery access to accommodate device delivery system.
- Target arteries for arch branches:
- < 24 mm diameter
- Adequate landing zone length to obtain proximal and distal seal.
- Free from dissection precluding adequate seal in distal landing zone of branch stent and severe tortuosity/thrombus/calcification.
- Aortic Arch Aneurysm
- Proximal aortic fixation zone:
- Native aorta or surgical graft
- Diameter: 20 - 42 mm
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
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