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

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Suprarenal Aortic Aneurysm; Penetrating Aortic Ulcer; Juxtarenal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm

Treatments: Device: Zenith t-Branch Endovascular Graft; Device: Cook Custom Aortic Endograft; Device: Surgeon-Modified Endograft

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02043691

201400001

Details and patient eligibility

About

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.

Full description

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 Angiography.

The participants will be followed for 5 years.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 >0.5cm 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. >2.0cm 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 premedicated
• Systemic or local infection that may increase the risk of endovascular graft infection.
• 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 repair.
• 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 components.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Cook Custom Aortic Endograft

Experimental group

Description:

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 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 or thoracoabdominal aorta. Grafts may include a combination of up to 5 fenestrations and branches.

Treatment:

Device: Cook Custom Aortic Endograft

Zenith t-Branch Endovascular Graft

Experimental group

Description:

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.

Treatment:

Device: Zenith t-Branch Endovascular Graft

Surgeon-Modified Endograft

Experimental group

Description:

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.

Treatment:

Device: Surgeon-Modified Endograft