RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2014-06
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02043691

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Juxtarenal, suprarenal and thoracoabdominal aortic pathology as follows in hemodynamically stable patients:
  2. 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.
  3. 1. Diameter \>5.5 cm if asymptomatic, or 5.0 cm with enlargement of \>0.5cm in 6 months.
  4. 2. History of growth \>0.5 cm per year
  5. 3. Any size if ruptured or symptomatic
  6. 2. Penetrating aortic ulcer (PAU)
  7. 1. \>2.0cm in depth
  8. 2. Any size if contained ruptured or symptomatic
  1. * Less than 18 years of age
  2. * Life expectancy less than 12 months based on the surgeon's assessment
  3. * Pregnant or breastfeeding or planning on becoming pregnant within 60 months
  4. * Inability or refusal to give informed consent
  5. * Unwilling or unable to comply with the follow-up schedule
  6. * Less than 30 days beyond primary endpoint for other investigative drug or device study

Contacts and Locations

Study Contact

Adam W Beck, MD
CONTACT
awbeck@uabmc.edu
Rebecca St John
CONTACT
rstjohn@uabmc.edu

Principal Investigator

Adam W Beck, MD
PRINCIPAL_INVESTIGATOR
University of Alabama at Bimingham

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-06
Study Completion Date2027-10

Study Record Updates

Study Start Date2014-06
Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

  • Endovascular
  • Aortic
  • Aneurysm
  • Thoracoabdominal
  • Juxtarenal
  • Suprarenal
  • Endograft
  • Fenestrated
  • Branched
  • Complex
  • Abdominal
  • Thoracic
  • Stent
  • Stentgraft

Additional Relevant MeSH Terms

  • Juxtarenal Aortic Aneurysm
  • Suprarenal Aortic Aneurysm
  • Thoracoabdominal Aortic Aneurysm
  • Penetrating Aortic Ulcer