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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lombard Medical
ClinicalTrials.gov Identifier:
NCT00442065
First received: February 28, 2007
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Abdominal Aortic Aneurysm
Device: Aorfix™ Stent Grafts (AAA endovascular procedure)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Lombard Medical:

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

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. [ Time Frame: 6-months post-procedure ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: October 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442065

Locations
Czech Republic
2 Interni Klinika; General University Hospital
Prague, Czech Republic, 12800
Germany
Klinik für Gefäßchirurgie; St.-Franziskus Hospital Münster
Munster, Germany, 48145
Poland
Department of Interventional Radiology, University School of Medicine
Lublin, Poland, 20954
Spain
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
Investigators
Principal Investigator: William C Loan, MD, FRCR Belfast City Hospital Trust, Belfast, Ireland
  More Information

Publications:
Responsible Party: Lombard Medical
ClinicalTrials.gov Identifier: NCT00442065     History of Changes
Other Study ID Numbers: 2003-001P2
Study First Received: February 28, 2007
Last Updated: October 15, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Comité Ético de Investigación Clínica

Keywords provided by Lombard Medical:
Abdominal aortic aneurysm study

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on August 28, 2014