RecruitingNot ApplicableNCT04746677

Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)

Single-Center Investigational Device Exemption Trial: Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)


Sponsor

Beth Israel Deaconess Medical Center

Enrollment

220 participants

Start Date

Mar 15, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of this study is to examine the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for endovascular repair of complex aortic pathology in high-risk patients. The study is divided into three study arms based on the subject's aortic pathology: (1) Complex abdominal aortic aneurysm (AAA); (2) Thoracoabdominal aortic aneurysm; and (3) Aortic dissection.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Endovascular aortic repair with a physician-modified endovascular graft (PMEG) and a medical device called TREO graft for people with abdominal aortic aneurysm, aortic dissection, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 21 Years and older.

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

DEVICEEndovascular aortic repair with a physician-modified endovascular graft (PMEG)

Endovascular aortic repair with a physician-modified endovascular graft (PMEG)

DEVICETREO graft

Endovascular aortic repair with a physician-modified endovascular graft (PMEG) using the TREO graft


Locations(1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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NCT04746677


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