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

Conditions:Cardiology, Cardiology, Cardiology, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology
Age Range:18 - Any
Start Date:June 2014
End Date:October 2023
Contact:Adam W Beck, MD

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Evaluation of All-Cause Mortality and Pulmonary Morbidity in Treating Juxtarenal, Suprarenal and Thoracoabdominal Aortic Pathologies Using the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft and Surgeon-Modified Endografts

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 aortic pathologies involving
the 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.

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:

Clinical Exam, Blood Tests, CT Scans (with and without contrast), Abdominal Device X-ray, and

The participants will be followed for 5 years.

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 >0.5cm in 6

2. History of growth >0.5 cm per year

3. Any size if ruptured or symptomatic

2. Penetrating aortic ulcer (PAU)

1. >2.0cm in depth

2. Any size if contained ruptured or symptomatic

General Exclusion Criteria:

- 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

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

- Systemic or local infection that may increase the risk of endovascular graft

- Baseline eGFR <30mL/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

- History of connective tissue disorders.

- 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.

- Aortic dissection.

- Infectious ("mycotic") etiology of the aortic disease.

- Significant occlusive disease or tortuosity precluding delivery of the device

- Proximal Landing zone <20mm in length. The proximal landing zone can be within zones 2
through 8, with least 20mm 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 <20mm in length if the landing zone is in the aorta, or <20mm 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 is indispensable (i.e. angiographic
visualization or a large IMA, filling of SMA via collaterals, stenosis of celiac or
SMA or oblique views) and the indispensible 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.
We found this trial at
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Adam W Beck, MD
Phone: 205-934-2006
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Birmingham, AL
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