Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal Aortic Aneurysms With Fenestrated Stent Grafts

Conditions
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Juxtarenal Aortic Aneurysms, Suprarenal Aortic Aneurysms, Type IV Thoracoabdominal Aortic Aneurysms

Intervention / Treatment
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* Device: Custom-made Zenith® Fenestrated AAA Endovascular Graft:


Participation Criteria
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Eligibility Criteria
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General Inclusion Criteria A patient may be included in the study if the patient has at least one of the following and is appropriate for treatment with a custom-made 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. General Exclusion Criteria 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 Life expectancy < 2-years Additional medical restrictions as specified in the Clinical Investigation Plan Additional anatomical restrictions as specified in the Clinical Investigation Plan

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Endovascular<br>The study will include patients treated by endovascular aortic repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft. The graft includes combinations of scallops, holes (fenestrations) or cuffs (side branches) . These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches. Other names: Endovascular stent Stent-graft | Device: Custom-made Zenith® Fenestrated AAA Endovascular Graft:<br>* 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.<br>* Other names: Stent-graft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects who have die at 30 days post treatment | Deaths 30 days after treatment | 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. | 30 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic aneurysm