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 study looks at a complex type of aortic repair called physician-modified endovascular grafts (PMEGs). The aorta is the body's main blood vessel, and sometimes it develops dangerous bulges (aneurysms) or tears (dissections) in areas that standard devices cannot reach. Doctors can customize grafts in the operating room to fit each patient's unique anatomy, and this study tracks how safe and effective those custom repairs are. The study has four groups: patients with complex abdominal aortic aneurysms, patients with large thoracoabdominal aneurysms, patients with aortic dissections, and patients who don't fit other categories but still have no other safe option. All participants must be at too high a risk for open surgery or unable to wait for a factory-made custom device. You may be eligible if... - You are 21 years or older with life expectancy of at least 2 years - You have a complex aortic aneurysm, dissection, or related problem that cannot be treated with standard approved devices - You are considered too high risk for open surgical repair - Your aorta has adequate attachment zones for the graft You may NOT be eligible if... - You are pregnant or breastfeeding - You have a ruptured aneurysm - You have a connective tissue disorder like Marfan syndrome or Ehlers-Danlos syndrome - You have an active systemic or local infection - You have known allergies to graft materials or contrast dye that cannot be managed 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

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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