ARBITER-II: Aorfix™ Bifurcated Safety and Performance Trial: Phase II, Angulated Vessels

Study Overview
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Brief Summary
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To assess the safety and performance of Aorfix™ Stent Grafts in the treatment of Abdominal Aortic and Aorto-Iliac Aneurysm where a significant degree of vessel angulation exists at the neck of the aneurysm or in the common iliac arteries.

Detailed Description
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The Aorfix™ Stent Graft is currently a CE-marked product indicated for AAA where the angle of the aneurysm is <65o. The objective of this study is to evaluate the safety and performance of the bifurcated Aorfix™ Stent Graft in the treatment of infrarenal abdominal aortic aneurysms and aorto-iliac aneurysms, in infrarenal necks angulated > 60o (between 60 to 90 degrees) as measured by 3-dimensional reconstruction in order to widen the indication. The investigation is a prospective open label, single arm, multi-centre clinical study. The study group will consist of 25 evaluable participants. In order to account for patients lost to follow up (estimated at approximately 20%) up to 30 patients will be enrolled in the study.

Official Title
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A Study to Assess the Acute Technical Success of Aorfix™ Stent Grafts in the Treatment of Abdominal Aortic and Aorto-Iliac Aneurysm Where a Significant Degree of Vessel Angulation Exists at the Neck of the Aneurysm

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: Aorfix™ Stent Grafts (AAA endovascular procedure)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of abdominal aortic aneurysm 50 mm or larger in diameter, 40 mm or larger in diameter if symptomatic (i.e. pain, embolisation), or documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery(ies), or any saccular aneurysm. Infrarenal neck with a minimum length of 15 mm and a neck angulation between 60° and 90°, as assessed in 3 dimensions. The iliac artery diameter must be of appropriate diameter (1 mm smaller than the device diameter), with an appropriate distal landing length. The tortuosity of the common or external iliac arteries or femoral arteries must be low to medium (refer to operations manual). Patient provides written informed consent. Patients >18 years who are suitable for endovascular repair. Patient fit for endovascular surgery, with a diameter at the access sites of 7mm or larger bilaterally. Patient has a life expectancy longer than the duration of the study. Exclusion Criteria: Patient has a ruptured aneurysm. Patient has insufficient length of proximal aneurysm neck (<15mm from aneurysm to lowest renal artery and <20 mm from the aneurysm to the SMA). Aneurysm extends above renal arteries. Proximal neck of aneurysm has significant loose thrombus associated with it, or significant circumferential calcifications. Pregnant or nursing patients. Patient unfit for bail-out surgery and appropriate anaesthesia. Patient with an acute or chronic aortic dissection or mycotic aneurysm (defined by localised asymmetric aneurysm sac). Patient has current non-localised infection. Patient has known allergy to graft materials, Nitinol, or contrast media. Patient's where imaging is problematic; an example is an obese patient. Patient has co-morbidities that deny vascular access, including small / tortuous access vessels.

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| Active Comparator: Open label, single arm<br>A prospective, open label, single-arm (non-randomized) multi-center, international clinical device investigation to collect safety and performance data concerning the Aorfix™ Stent Graft System in the treatment of abdominal aortic aneurysm and aorto-iliac aneurysm where a significant degree of vessel angulation exists | Device: Aorfix™ Stent Grafts (AAA endovascular procedure)<br>* Endovascular treatment of AAA using the Aorfix™ Stent Graft and Delivery System<br>* Other names: Aorfix™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoints are acute technical success, initial performance and safety at 1-month follow up. |  | 1-month post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoints will examine recovery factors: operative time, ICU duration, blood loss, days to normal diet, days to discharge, days to ambulation, freedom from non-clinical events, need for secondary procedure and conversion to uni-iliac. |  | 6-months post-procedure | 
| As well as safety at 6-month follow-up as measured by serious adverse events that occur up to 6-months post-procedure. |  | 6-months post-procedure | 

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