RecruitingNot ApplicableNCT02089607

CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft

Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal, Thoracoabdominal and Aortic Arch Aneurysms or Dissections With Fenestrated and Branched Stent Grafts


Sponsor

Baylor College of Medicine

Enrollment

760 participants

Start Date

Mar 1, 2014

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and/or branches to repair aortic aneurysm.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests specialized endovascular stent grafts with fenestrations (openings) and branches to repair complex aortic aneurysms in the chest and abdomen — including those involving the major arteries that supply the kidneys and intestines. These are complex procedures for patients who cannot safely undergo traditional open surgery. You may be eligible if: - You are 18 years of age or older - You have a thoracoabdominal aortic aneurysm that is 5.5 cm or larger, growing rapidly, saccular in shape, or involves the aortic arch - You are willing to comply with the follow-up schedule - You are able to provide informed consent You may NOT be eligible if: - You are under 18 years old - You are pregnant or breastfeeding - You have a life expectancy under 2 years - You have known allergies to device materials (stainless steel, nitinol, polyester, PTFE, gold, urethane) - You have an active infection, mycotic aneurysm, or connective tissue disorder (such as Marfan syndrome) - Your aneurysm is ruptured with low blood pressure (hemodynamic instability) - You have uncorrectable coagulopathy (serious blood clotting disorder) 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

DEVICECAAA and TAAA Arm

The Zenith Fenestrated-Branched System is a tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft open. The graft will be inserted through arteries in the leg (called endovascular repair). This procedure uses catheters that go inside the blood vessel to place a stent graft above and below the aneurysm. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches). One or more than one of the study devices including the Zenith® Fenestrated AAA Endovascular Graft, Zenith® t-Branch Endovascular Graft, Patient-Specific Thoracoabdominal Graft, Patient-Specific Distal Bifurcated Component, and Zenith® Branch Endovascular Graft-Iliac Bifurcation will be implanted. The arteries to the liver, intestine, and kidneys will have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.

DEVICEAortic Arch Aneurysm Arm

The Zenith® Arch Branch Endovascular Graft includes the main aortic arch portion and one to three cuffs (side branches) that allow the graft to be located in the aortic arch. The number of cuffs is decided based on the anatomy of your aneurysm. The arteries in the aortic arch are the innominate artery (Zone 0), left common carotid artery (Zone 1) and the left subclavian artery (Zone 2). These arteries supply the right arm and right side of the brain, the left side of the brain and the left arm, respectively. The main aortic endovascular graft will be connected into the innominate artery, left common carotid artery and left subclavian artery using additional stents into the branch vessels.


Locations(3)

Mayo Clinic

Rochester, Minnesota, United States

Baylor College of Medicine

Houston, Texas, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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

Visit

NCT02089607


Related Trials