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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00442065
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : October 17, 2012
Information provided by (Responsible Party):
Lombard Medical

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.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Device: Aorfix™ Stent Grafts (AAA endovascular procedure) Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 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
Device: Aorfix™ Stent Grafts (AAA endovascular procedure)
Endovascular treatment of AAA using the Aorfix™ Stent Graft and Delivery System
Other Name: Aorfix™

Primary Outcome Measures :
  1. The primary endpoints are acute technical success, initial performance and safety at 1-month follow up. [ Time Frame: 1-month post-procedure ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 6-months post-procedure ]
  2. As well as safety at 6-month follow-up as measured by serious adverse events that occur up to 6-months post-procedure. [ Time Frame: 6-months post-procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00442065

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Czech Republic
2 Interni Klinika; General University Hospital
Prague, Czech Republic, 12800
Klinik für Gefäßchirurgie; St.-Franziskus Hospital Münster
Munster, Germany, 48145
Department of Interventional Radiology, University School of Medicine
Lublin, Poland, 20954
Vascular Surgery Division, Thoracic Institute, Hospital Clinic, University of Barcelona
Barcelona, Spain, 08036
United Kingdom
Belfast City Hospital Trust
Belfast, United Kingdom
Freeman Hospital; Main X-Ray
Newcastle upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Lombard Medical
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Principal Investigator: William C Loan, MD, FRCR Belfast City Hospital Trust, Belfast, Ireland
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Responsible Party: Lombard Medical Identifier: NCT00442065    
Other Study ID Numbers: 2003-001P2
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: October 17, 2012
Last Verified: October 2012
Keywords provided by Lombard Medical:
Abdominal aortic aneurysm study
Additional relevant MeSH terms:
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Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases