Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Study Overview
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Brief Summary
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Purpose of this study: The purpose of the study is to evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the treatment of abdominal aortic, aorto-iliac and common iliac aneurysms with anatomies including angled aorta, angled aneurysmal body, or both, between 0° and 90°. Study hypothesis: The primary efficacy hypothesis is the proportion of grafts remaining free from endoleak, migration, and fracture at 12 months. Efficacy: The 12 month, all cause mortality rate in the Aorfix™ group will be non-inferior to the 12 month, all cause mortality rate in the Open Control group. Safety: The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups will be non-inferior to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group.

Official Title
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Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Conditions
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Abdominal Aortic Aneurysms

Intervention / Treatment
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* Procedure: Open surgical repair
* Device: Stent Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed abdominal aortic aneurysm > 4.5 cm in diameter, OR 4.0 cm or larger in diameter if symptomatic (i.e. pain, embolization), OR documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery (ies), and/or Iliac aneurysm greater than, or equal to 3.5 cm in maximum diameter. Exclusion Criteria: Less than 21 years of age, Life expectancy less than 2 years, Pregnant, Religious cultural or other objection to the receipt of blood or blood products, Unwilling to comply with follow-up schedule, Unwillingness or inability to provide informed consent to both trial and procedure. Patients not expected to live more than 2 years from enrollment Patient has a ruptured aneurysm Aneurysm extends above renal arteries Proximal neck of aneurysm has significant loose thrombus associated with it Patient with an acute or chronic aortic dissection or mycotic aneurysm Patient has current non-localized infection (may be recruited following remission of the infection) Patient is allergic to device materials Patient is allergic to or intolerant of use of contrast media and cannot be exposed to suitable remedial treatment such as steroids and/or benadryl Patient is clinically and morbidly obese such that imaging would be severely adversely affected Patient has renal failure (serum creatinine > 2.5 mg/dL) Patient has an uncorrectable bleeding abnormality Patient has unstable angina Patient is receiving dialysis: Inflammatory aneurysm MI in last 6 months End stage COPD Patient has connective tissue disease (eg Marfan syndrome, Ehlers-Danlos syndrome) Significant (>80%) renal artery stenosis which cannot be readily treated

Ages Eligible for Study
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Minimum Age: 21 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open Surgical Repair<br>Open surgical repair of abdominal aortic aneurysm. All patient enrollment and 2-year follow-ups completed. | Procedure: Open surgical repair<br>* Open surgical repair of abdominal aortic aneurysm<br>|
| Experimental: Endovascular Repair<br>Endovascular treatment arm of 160 patients having suitable anatomy for the Aorfix™ AAA Flexible Stent Graft System. Use of stent grafts in aortic angles greater than 60° has not been approved for other devices available in the US. As a result, a minimum of 120 patients in this arm will have an aortic angle between 60° and 90°. Patient recruitment completed; 5-year follow-up evaluations continue. | Device: Stent Graft<br>* Endovascular repair of abdominal aortic aneurysm (EVAR)<br>* Other names: Aorfix™ AAA stent graft;|
| Experimental: Continued Access<br>Endovascular treatment arm of 50 patients maximum having suitable anatomy for the Aorfix™ AAA Flexible Stent Graft System. This Arm will provide active sites with ongoing device access while FDA reviews the PMA. Patient recruitment completed; 5-year patient follow-ups continue. | Device: Stent Graft<br>* Endovascular repair of abdominal aortic aneurysm (EVAR)<br>* Other names: Aorfix™ AAA stent graft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aorfix™ vs. Open Control All Cause Mortality | The 12 month, all cause mortality rate in the Aorfix™ group compared to all cause mortality rate in the Open Control group. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aorfix™ vs. Open Control Adverse Events | The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups compared to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stent Graft, AAA, Abdominal Aortic Aneurysms, Endovascular, EVAR, Aorta, Stent, Tortuous, High Angle, Angled Necks