RecruitingNot ApplicableNCT02050113

Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices

Sponsor

Andres Schanzer

Enrollment

600 participants

Start Date

Mar 1, 2014

Study Type

INTERVENTIONAL

Conditions

Ehlers-Danlos Syndrome Complex Aortic Aneurysms Thoracoabdominal Aneurysms Pararenal Aneurysms Juxtarenal Aneurysms Marfan Syndrome Loeys-Dietz Syndrome Aortic Arch Aneurysm

Summary

The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysms and aortic arch aneurysms who (1) have anatomy not suitable for endovascular repair using grafts currently marketed in the United States,(2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests physician-modified or custom-made endovascular grafts (devices inserted through blood vessels to repair the aorta) in patients with complex aortic aneurysms that cannot be treated with standard commercially available devices. It is designed for patients who face high surgical risk from open repair. You may be eligible if: - You are 18 years of age or older - You have an aortic or aortoiliac aneurysm that is 5.5 cm or larger, growing rapidly, or causing symptoms - Your aneurysm cannot be treated with currently available approved devices - You are considered high risk for open surgery (due to previous abdominal surgery, heart disease, age over 70, COPD, or similar factors) - You are willing and able to comply with 5-year follow-up You may NOT be eligible if: - You object to receiving blood or blood products - You are allergic to device materials (stainless steel, polyester, nitinol, gold) - You have uncontrolled blood clotting (coagulopathy) - You have an active malignancy with life expectancy less than 2 years - You have unstable angina - Your aneurysm anatomy does not meet device specifications 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 Fenestrated or Branched Stent Graft

The surgeon will place a custom made graft, t-Branch device or modify commercially available stent grafts to match the anatomy of the patient being treated. Small fenestrations (holes) will be made in the stent graft so that additional stents can be inserted through the fenestration and into the blood vessels that lead to the kidneys, intestines or liver. These stents allow blood to flow freely to these organs. If the aneurysm is in the aortic arch stents may be placed in the carotid and subclavian arteries. This surgery is done through small incisions in the groin and sometimes in the upper arm.