Study of Cook Custom Aortic Endograft, Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft for Aortic Conditions
This study is looking at three special devices to treat serious problems with your aorta (the body's main artery). These devices are the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endografts. They are designed for people with conditions like juxtarenal, suprarenal, thoracoabdominal, or aortic arch aneurysms (bulges in the artery wall) or penetrating aortic ulcers, especially when these conditions are near important blood vessels. The goal is to see if these devices are safe and work well, potentially leading to shorter hospital stays and fewer complications. You could be eligible if you are 18 or older and have one of these aortic conditions, with specific size requirements for aneurysms.
- Study design
- This is a single-center study planning to enroll 410 participants. It is an interventional study, meaning participants will receive one of the study devices.
- What's involved
- After signing consent, you will have tests like clinical exams, blood tests, and CT scans to determine eligibility and which device will be used. You will then be followed for 5 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 5 years after the procedure.
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NCT02043691
Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft in Treating Aortic Pathologies
Recruiting
NAAges 18+InterventionalTreatmentUniversity of Alabama at BirminghamInvestigator-initiated
~410 participants
Updated 2026-01-06 on ClinicalTrials.gov
What's tested:Cook Custom Aortic EndograftZenith t-Branch Endovascular GraftSurgeon-Modified Endograft
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of major adverse events at 30 days post primary procedure
Measured over 30 days post primary procedure
Conditions
Where it's being run
1 sites across 1 statesAlabama1
Study leadership
- Adam W Beck, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Bimingham
Who to contact
Adam W Beck, MD
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Juxtarenal, suprarenal, and thoracoabdominal aortic pathology as follows in hemodynamically stable patients:
Aortic Arch pathology:
Aortic Arch Aneurysm
Aortic Dissection
Exclusion
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.
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 investigational 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.
What this trial measures
- Rate of major adverse events at 30 days post primary procedure30 days post primary procedure