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.
Aortic or aortoiliac aneurysm with diameter ≥5.5 cm
Aortic or aortoiliac aneurysm with a history of growth ≥1.0 cm per year, or clinical indication for aneurysm repair based on symptoms
Cannot be treated with a currently available non-modified approved device
Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device
Exclusion Criteria Medical Exclusion Criteria
Cultural objection to receipt of blood or blood products
Allergy or sensitivity to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol
Anaphylactic reaction to contrast that cannot be adequately pre-medicated
Single group
Custom Made Fenestrated or Branched Stent Graft
DeviceThe 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.
The effectiveness of physician modified endovascular grafts will be determined by evaluating the proportion of patients that achieve Treatment Success
Treatment success is a combination of technical success, and freedom at 12 months from the following: Type 1 and 3 Endoleaks, Stent migration of more than 10 mm, aortic aneurysm enlargement sac enlargement of more than 5 mm, aneurysm rupture and conversion to open repair.
Incidence of Major Adverse Events
Major adverse events include death, myocardial infarction, stroke, respiratory failure, paralysis, bowel ischemia, and procedural blood loss of greater than 1 liter.
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Andres Schanzer
Lead sponsor
University of Massachusetts, Worcester
Sponsor institution
