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

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Disease Information

Descriptive Information
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 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
Study Design † Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † The primary endpoints are acute technical success, initial performance and safety at 1-month follow up.
Secondary Outcome Measure † 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 † DeviceAorfix™ Stent Grafts (AAA endovascular procedure)
Study Arms / Comparison Groups Open label, single arm 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 (
Gender Both
Ages 19 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Czech Republic
Administrative Information
NCT ID † NCT00442065
Organization ID 2003-001P2
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Lombard Medical
Collaborators ††
Investigators † Principal Investigator: William C Loan, MD, FRCR, Belfast City Hospital Trust, Belfast, Ireland
Information Provided By
Verification Date October 2012
First Received Date † February 28, 2007
Last Updated Date October 15, 2012
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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