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

NCT ID: NCT00442065

Last Updated: 2012-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-04-30

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal aortic aneurysm study

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study 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

Group Type: ACTIVE_COMPARATOR

Aorfix™ Stent Grafts (AAA endovascular procedure)

Intervention Type: DEVICE

Endovascular treatment of AAA using the Aorfix™ Stent Graft and Delivery System

Interventions

Aorfix™ Stent Grafts (AAA endovascular procedure)

Endovascular treatment of AAA using the Aorfix™ Stent Graft and Delivery System

Intervention Type: DEVICE

Other Intervention Names

Aorfix™

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lombard Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William C Loan, MD, FRCR

Role: PRINCIPAL_INVESTIGATOR

Belfast City Hospital Trust, Belfast, Ireland

Locations

2 Interni Klinika; General University Hospital

Prague, , Czechia

Klinik für Gefäßchirurgie; St.-Franziskus Hospital Münster

Münster, , Germany

Department of Interventional Radiology, University School of Medicine

Lublin, , Poland

Vascular Surgery Division, Thoracic Institute, Hospital Clinic, University of Barcelona

Barcelona, , Spain

Belfast City Hospital Trust

Belfast, , United Kingdom

Freeman Hospital; Main X-Ray

Newcastle upon Tyne, , United Kingdom

Countries

Czechia; Germany; Poland; Spain; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 11013038 (View on PubMed)

Other Identifiers

2003-001P2

Identifier Type: -

Identifier Source: org_study_id