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

Description

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.

Conditions

Juxtarenal Aortic Aneurysm, Suprarenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Penetrating Aortic Ulcer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Juxtarenal Aortic Aneurysm
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

Adam W Beck, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Bimingham

Study Record Dates

2027-10