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

This study is currently recruiting participants.
Verified by Lombard Medical, September 2007

Sponsored by: Lombard Medical
Information provided by: Lombard Medical
ClinicalTrials.gov Identifier: NCT00442065
  Purpose

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.


Condition Intervention Phase
Abdominal Aortic Aneurysm
Device: AorfixTM Stent Grafts (AAA endovascular procedure)
Phase II
Phase III

MedlinePlus related topics:   Aneurysms   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   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

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 ]

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 ]
  • 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 ]

Estimated Enrollment:   30
Study Start Date:   October 2006
Estimated Study Completion Date:   February 2009

Detailed Description:

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.

  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

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

Contacts
Contact: William C Loan, M.D.     +44-28-9032.9241     willie.loan@bch.n-i.nhs.uk    

Locations
Czech Republic
2 Interni Klinika; General University Hospital     Not yet recruiting
      Prague, Czech Republic, 12800
      Contact: Dr. Petr Varejka, MD            
      Principal Investigator: Petr Varejka, MD            
Germany
Klinik für Gefäßchirurgie; St.-Franziskus Hospital Münster     Recruiting
      Munster, Germany, 48145
      Contact: Dr. Jorg Tessarek, MD            
      Principal Investigator: Jorg Tessarek, MD            
Poland
Department of Interventional Radiology, University School of Medicine     Recruiting
      Lublin, Poland, 20954
      Contact: Prof. M. Trojanowska, MD            
      Principal Investigator: M. Trojanowska, MD            
Spain
Vascular Surgery Division, Thoracic Institute, Hospital Clinic, University of Barcelona     Recruiting
      Barcelona, Spain, 08036
      Contact: Prof. Vincent Riambau, MD            
      Principal Investigator: Vincent Riambau, MD            
United Kingdom
Belfast City Hospital Trust     Recruiting
      Belfast, United Kingdom
      Principal Investigator: Willie Loan, MD            
Freeman Hospital; Main X-Ray     Recruiting
      Newcastle upon Tyne, United Kingdom, NE7 7DN
      Contact: Dr. John Rose, MD            
      Principal Investigator: John Rose, MD            

Sponsors and Collaborators
Lombard Medical

Investigators
Principal Investigator:     William C Loan, MD, FRCR     Belfast City Hospital Trust, Belfast, Ireland    
  More Information

Publications:

Study ID Numbers:   2003-001P2
First Received:   February 28, 2007
Last Updated:   September 10, 2007
ClinicalTrials.gov Identifier:   NCT00442065
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  

Study placed in the following topic categories:
Aortic Diseases
Aneurysm
Aortic Aneurysm, Abdominal
Abdominal aortic aneurysm
Vascular Diseases
Iliac Aneurysm
Aortic Aneurysm

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 04, 2008




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