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

Primary Purpose

Abdominal Aortic Aneurysm

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Aorfix™ Stent Grafts (AAA endovascular procedure)

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring Abdominal aortic aneurysm study

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

2 Interni Klinika; General University Hospital
Klinik für Gefäßchirurgie; St.-Franziskus Hospital Münster
Department of Interventional Radiology, University School of Medicine
Vascular Surgery Division, Thoracic Institute, Hospital Clinic, University of Barcelona
Belfast City Hospital Trust
Freeman Hospital; Main X-Ray

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Open label, single arm

Arm Description

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

Outcomes

Primary Outcome Measures

The primary endpoints are acute technical success, initial performance and safety at 1-month follow up.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00442065

First Posted

February 28, 2007

Last Updated

October 15, 2012

Sponsor

Lombard Medical

1. Study Identification

Unique Protocol Identification Number

NCT00442065

Brief Title

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

Acronym

ARBITER-II

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

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lombard Medical

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abdominal Aortic Aneurysm

Keywords

Abdominal aortic aneurysm study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open label, single arm

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Aorfix™ Stent Grafts (AAA endovascular procedure)

Other Intervention Name(s)

Aorfix™

Intervention Description

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

Primary Outcome Measure Information:

Title

The primary endpoints are acute technical success, initial performance and safety at 1-month follow up.

Time Frame

1-month post-procedure

Secondary Outcome Measure Information:

Title

Time Frame

6-months post-procedure

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William C Loan, MD, FRCR

Organizational Affiliation

Belfast City Hospital Trust, Belfast, Ireland

Official's Role

Principal Investigator

Facility Information:

Facility Name

2 Interni Klinika; General University Hospital

City

Prague

ZIP/Postal Code

12800

Country

Czech Republic

Facility Name

Klinik für Gefäßchirurgie; St.-Franziskus Hospital Münster

City

Munster

ZIP/Postal Code

48145

Country

Germany

Facility Name

Department of Interventional Radiology, University School of Medicine

City

Lublin

ZIP/Postal Code

20954

Country

Poland

Facility Name

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

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Belfast City Hospital Trust

City

Belfast

Country

United Kingdom

Facility Name

Freeman Hospital; Main X-Ray

City

Newcastle upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

11013038

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.

Results Reference

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

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