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ARBITER-II: AorfixTM Bifurcated Safety and Performance Trial: Phase II, Angulated Vessels
This study is ongoing, but not recruiting participants.
Study NCT00442065   Information provided by Lombard Medical
First Received: February 28, 2007   Last Updated: September 18, 2008   History of Changes

February 28, 2007
September 18, 2008
October 2006
October 2008   (final data collection date for primary outcome measure)
The primary endpoints are acute technical success, initial performance and safety at 1-month follow up. [ Time Frame: 1-month post-procedure ]
The primary endpoints are acute technical success, initial performance and safety at 1-month follow up.
Complete list of historical versions of study NCT00442065 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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.
  • As well as safety at 6-month follow-up as measured by serious adverse events that occur up to 6-months post-procedure.
 
ARBITER-II: AorfixTM Bifurcated Safety and Performance Trial: Phase II, Angulated Vessels
A Study to Assess the Acute Technical Success of AorfixTM 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

To assess the safety and performance of AorfixTM 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.

The AorfixTM 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 AorfixTM 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.

Phase II, Phase III
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Abdominal Aortic Aneurysm
Device: AorfixTM Stent Grafts (AAA endovascular procedure)
 
Harris PL, Vallabhaneni SR, Desgranges P, Becquemin JP, van Marrewijk C, Laheij RJ. Incidence and risk factors of late rupture, conversion, and death after endovascular repair of infrarenal aortic aneurysms: the EUROSTAR experience. European Collaborators on Stent/graft techniques for aortic aneurysm repair. J Vasc Surg. 2000 Oct;32(4):739-49.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
30
February 2009
October 2008   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   Poland,   Spain,   United Kingdom
 
NCT00442065
 
2003-001P2
Lombard Medical
 
Principal Investigator: William C Loan, MD, FRCR Belfast City Hospital Trust, Belfast, Ireland
Lombard Medical
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP