RecruitingNot ApplicableNCT02323581

Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts

Feasibility, Safety, and Clinical Outcomes of Endovascular Treatment of Thoracoabdominal Aortic Aneurysms and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts

Sponsor

Darren Schneider, M.D.

Enrollment

520 participants

Start Date

Nov 1, 2013

Study Type

INTERVENTIONAL

Conditions

Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Thoracic Aortic Dissection, Thoracoabdominal

Summary

Prospective, nonrandomized, single-center, two-arm study to assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Endovascular treatment of Aortic Arch Aneurysms and a medical device called Endovascular treatment of Thoracoabdominal Aortic Aneurysm for people with aortic aneurysm, thoracic, aortic aneurysm, thoracoabdominal, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 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 treatment of Thoracoabdominal Aortic Aneurysm

A TAAA is an abnormal enlargement (ballooning out) of the main artery (the aorta) and involves all or part of the aorta in your chest as well as all or part of the aorta in the abdomen. It also involves the part of the aorta where the arteries that bring blood to the liver, stomach and intestines and kidneys are attached. This investigational procedure that is being studied uses stent-grafts (cylindrical fabric tubes (grafts), with metal springs (stents) attached). The stent-grafts are placed inside the aneurysmal (weakened) area of the aorta to re-line it. These customized stent-grafts have special branches attached to them or openings (called "fenestrations") that are used to keep blood flowing to the arteries that supply the liver, stomach, intestines and kidneys. The investigational stent graft will be designed and custom-made specifically for your aneurysm.

DEVICEEndovascular treatment of Aortic Arch Aneurysms

An aortic arch aneurysm is an abnormal enlargement (ballooning out) of the main artery (the aorta). The ascending aorta and aortic arch is the first part of the vessel as it exits the heart and makes a turn around the area of the collar bone. This part of the aorta gives branches that supply the head, brain and arms. The arch branch endovascular graft includes the main aortic arch portion and one to three cuffs (side branches) that allow the graft to be located in the aortic arch. The number of cuffs is decided based on the anatomy of your aneurysm. The arteries in the aortic arch are the innominate artery (Zone 0), left common carotid artery (Zone 1) and the left subclavian artery (Zone 2). These arteries supply the right arm and right side of the brain, the left side of the brain and the left arm, respectively.