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.
This is a traditional device feasibility study intended to generate preliminary safety and efficacy information that may be used to plan an appropriate future study, or to inform further product development.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The 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.
Mayo Clinic
Rochester, Minnesota, United States
ACTIVE_NOT_RECRUITINGThe University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGNumber of subjects who have die at 30 days post treatment
Deaths 30 days after treatment
Time frame: 30 days post 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.
Time frame: 30 days post treatment
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).
Time frame: baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years.
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.
Time frame: 12 months
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