RecruitingNot ApplicableNCT02043691

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

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


Sponsor

University of Alabama at Birmingham

Enrollment

410 participants

Start Date

Jun 1, 2014

Study Type

INTERVENTIONAL

Conditions

Summary

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 Juxtarenal, Suprarenal, Thoracoabdominal, and Aortic Arch pathologies involving the at least one brachiocephalic artery or 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates specialized endovascular (minimally invasive, catheter-based) devices for treating complex aortic aneurysms and other serious aortic diseases — including aneurysms near the kidney arteries, in the chest, or involving the aortic arch. This approach is for patients who are considered too high risk for open surgery. You may be eligible if: - You are 18 years of age or older - You have an aortic or aortoiliac aneurysm meeting specific size or growth criteria - You have been assessed as high risk for standard open surgery - You are willing and able to comply with 5 years of follow-up - You have not had major surgery within the past 30 days You may NOT be eligible if: - You are under 18 years old - You are pregnant or breastfeeding - You have a life expectancy less than 12 months - You have an active infection or allergy to device materials (stainless steel, polyester, nitinol, gold) - You have severe kidney disease (eGFR < 30 and not on dialysis) - You have a mycotic (infectious) aortic aneurysm or aortic injury from trauma - You refuse blood transfusions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICECook 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 aorta, thoracoabdominal aorta, or the aortic arch aorta. Grafts may include a combination of up to 5 fenestrations and/or branches.

DEVICEZenith 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.

DEVICESurgeon-Modified Endograft

The Surgeon-Modified Endografts are 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.


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT02043691


Related Trials