Clinical trial NCT00442065: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal aortic aneurysm study
Lead sponsor: Lombard Medical
Sponsor class: INDUSTRY
First posted: 2007-03-01
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The primary endpoints are acute technical success, initial performance and safety at 1-month follow up.
timeFrame: 1-month post-procedure
Secondary outcomes:
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.
timeFrame: 6-months post-procedure
measure: As well as safety at 6-month follow-up as measured by serious adverse events that occur up to 6-months post-procedure.
timeFrame: 6-months post-procedure
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: 2 Interni Klinika; General University Hospital
city: Munster
country: Germany
facility: Klinik für Gefäßchirurgie; St.-Franziskus Hospital Münster
city: Lublin
country: Poland
facility: Department of Interventional Radiology, University School of Medicine
city: Barcelona
country: Spain
facility: Vascular Surgery Division, Thoracic Institute, Hospital Clinic, University of Barcelona
city: Belfast
country: United Kingdom
facility: Belfast City Hospital Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital; Main X-Ray
Study officials:
affiliation: Belfast City Hospital Trust, Belfast, Ireland
name: William C Loan, MD, FRCR
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1067/mva.2000.109990.