RecruitingNot ApplicableNCT01937949

Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts

Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal Aortic Aneurysms With Fenestrated Stent Grafts

Sponsor

Gustavo S Oderich

Enrollment

200 participants

Start Date

Aug 1, 2013

Study Type

INTERVENTIONAL

Conditions

Juxtarenal Aortic Aneurysms Suprarenal Aortic Aneurysms Type IV Thoracoabdominal Aortic Aneurysms

Summary

The purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal, and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a customized endovascular stent-graft device (Zenith Fenestrated AAA Graft) designed to repair complex aortic aneurysms that are located near or involve the kidney and intestinal arteries. Instead of open surgery, the device is inserted through the blood vessels and expanded in place, with specially placed openings (fenestrations) to preserve blood flow to vital nearby organs. You may be eligible if... - You are 18 years old or older - You have a complex abdominal or thoracoabdominal aortic aneurysm measuring 5 cm or more, growing 0.5 cm or more per year, or at significant risk of rupture - Your anatomy is suitable for the fenestrated device as assessed by your surgeon - You are willing to comply with follow-up appointments You may NOT be eligible if... - You are pregnant or breastfeeding - Your life expectancy is less than 2 years - You are unable or unwilling to give informed consent - Your anatomy does not meet device requirements 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.

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Interventions

DEVICECustom-made Zenith® Fenestrated AAA Endovascular Graft:

The graft will be inserted through arteries in the groin (called endovascular repair). Endovascular repair is a procedure that uses catheters that go inside your blood vessel to place a stent graft above and below the aneurysm. This procedure lines the aneurysm with a new lining (stent) so blood does not fill the artery any more.

Locations(2)

Mayo Clinic

Rochester, Minnesota, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT01937949