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

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 is evaluating the safety and effectiveness of customized or physician-modified endovascular grafts for repairing complex aortic aneurysms — dangerous enlargements of the main artery — in patients whose anatomy makes standard commercial devices unsuitable or who cannot safely wait for a custom device to be manufactured. The repairs are performed through small groin incisions using stent grafts with additional openings to maintain blood flow to vital organs like the kidneys and intestines. Adults aged 18 and older with aortic aneurysms of 5.5 cm or larger, or rapidly growing smaller aneurysms, who are at high risk for open surgery may be eligible. Participation involves undergoing the endovascular repair procedure and follow-up imaging and clinic visits for up to five years. This summary was prepared to help patients understand the study in plain language.

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.


Locations(1)

UMass Memorial Health Care - University Campus

Worcester, Massachusetts, United States

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NCT02050113


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