Status:
COMPLETED
ARBITER-II: Aorfix™ Bifurcated Safety and Performance Trial: Phase II, Angulated Vessels
Lead Sponsor:
Lombard Medical
Conditions:
Abdominal Aortic Aneurysm
Eligibility:
All Genders
19+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 ane...
Detailed Description
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 bifurc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00442065
Start Date
October 1 2006
End Date
April 1 2009
Last Update
October 17 2012
Active Locations (6)
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1
2 Interni Klinika; General University Hospital
Prague, Czechia, 12800
2
Klinik für Gefäßchirurgie; St.-Franziskus Hospital Münster
Münster, Germany, 48145
3
Department of Interventional Radiology, University School of Medicine
Lublin, Poland, 20954
4
Vascular Surgery Division, Thoracic Institute, Hospital Clinic, University of Barcelona
Barcelona, Spain, 08036