The purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal, and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft.
Juxtarenal, suprarenal or type IV thoracoabdominal aortic aneurysm with a diameter ≥ 5.0 cm or 2 times the normal aortic diameter
Aneurysm with a history of growth ≥ 0.5 cm per year
Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.
Less than 18 years of age
Unwilling to comply with the follow-up schedule
Inability or refusal to give informed consent by the patient or a legally authorized representative
Pregnant or breastfeeding
Single group
Custom-made Zenith® Fenestrated AAA Endovascular Graft:
DeviceThe graft will be inserted through arteries in the groin (called endovascular repair). Endovascular repair is a procedure that uses catheters that go inside your blood vessel to place a stent graft above and below the aneurysm. This procedure lines the aneurysm with a new lining (stent) so blood does not fill the artery any more.
Number of subjects who have die at 30 days post treatment
Deaths 30 days after treatment
Number of subjects who experience a Major Adverse Event at 30 days post treatment
A Major Adverse Event includes any of the following: bowel ischemia, myocardial infarction (heart attack), paraplegia, renal failure, respiratory failure, stroke, or blood loss greater than 1000 ml.
Subject Scores on Short Form-36 (SF-36) Quality of Life Questionnaire
Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).
Number of Subjects Who Achieve Treatment Success
Treatment success is defined by a composite end-point, which includes all the following criteria described below: * Technical success, defined as successful delivery and deployment of the custom-made endovascular graft with preservation of those branch vessels intended to be preserved. * Freedom from type I or III endoleak. * Freedom from stent-graft migration. * Freedom from aneurysm enlargement \>5mm * Freedom from aneurysm rupture or conversion to open repair.
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Gustavo S Oderich
Lead sponsor
Baylor College of Medicine
Sponsor institution
Cook Group Incorporated
Collaborator
