Brief Title
ARBITER-II: Aorfix™ Bifurcated Safety and Performance Trial: Phase II, Angulated Vessels
Official Title
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
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 aneurysm or in the common iliac arteries.
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 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.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
The primary endpoints are acute technical success, initial performance and safety at 1-month follow up.
Secondary Outcome
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.
Condition
Abdominal Aortic Aneurysm
Intervention
Aorfix™ Stent Grafts (AAA endovascular procedure)
Study Arms / Comparison Groups
Open label, single arm
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
30
Start Date
October 2006
Completion Date
April 2009
Primary Completion Date
April 2009
Eligibility Criteria
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.
Gender
All
Ages
19 Years - N/A
Accepts Healthy Volunteers
No
Contacts
William C Loan, MD, FRCR, ,
Location Countries
Czech Republic
Location Countries
Czech Republic
Administrative Informations
NCT ID
NCT00442065
Organization ID
2003-001P2
Responsible Party
Sponsor
Study Sponsor
Lombard Medical
Study Sponsor
William C Loan, MD, FRCR, Principal Investigator, Belfast City Hospital Trust, Belfast, Ireland
Verification Date
October 2012