Acute endovascular treatment to improve outcome of ruptured aorto-iliac aneurysms

ISRCTN ISRCTN66212637
DOI https://doi.org/10.1186/ISRCTN66212637
Secondary identifying numbers NTR85; 2002B197
Submission date
12/09/2005
Registration date
12/09/2005
Last edited
19/03/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr R Balm
Scientific

Academic Medical Centre
Department of Vascular Surgery G4-111.1
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone +31 (0)20 5667832
Email r.balm@amc.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Patient information material can be found at: http://www.amc.nl/index.cfm?pid=1132 (in Dutch only)
Scientific title
Study acronymAJAX
Study objectivesAcute endovascular treatment improves outcome of ruptured aorto-iliac aneurysms.

Please note that as of 19/10/2007 the anticipated end date of this trial was extended from 01/10/2007 to 01/08/2008.

As of 12/09/2008 the anticipated end date was again extended to 01/10/2010. At this time, the record was also updated to include an enlarged target number of participants. The previous target number of participants was 80.

Patient inclusion completed with 116 patients on 17/02/2011
Ethics approval(s)Ethics approval received from the MEC of the Academic Medical Center in Amsterdam (certified MEC) on the 28th August 2003 (ref: MEC 03/161). A protocol amendment was approved on 26th November 2008.
Health condition(s) or problem(s) studiedRuptured aorto-iliac aneurysms
InterventionCT angiography: all patients with suspected rupture of an abdominal aortic aneurysm will be examined by CT angiography to confirm the diagnosis of a ruptured aneurysm and to evaluate the anatomical suitability for endovascular treatment. The patient is entered in the study if the aneurysm is ruptured, the anatomical criteria for endovascular repair are fulfilled and the patient is fit for an open procedure. Patients will then be randomised for either open or endovascular treatment. If possible informed consent is obtained, if the clinical condition of the patient does not allow for a proper informed consent, informed consent will be asked after the patient has been treated (in accordance with Dutch Law: WMO §2, artikel 6-1).

Open procedure: patient under general anesthesia, laparotomy, standard aortic repair with either an aortic tube graft or a bifurcated graft, standard closure.

Endovascular procedure: Local anesthesia of both groin regions, dissection of the common femoral arteries, placement of aorto-uni-iliac endovascular graft through one of the femoral arteries and placement of an iliac occluder in the contralateral iliac artery, placement of a femoro-femoral cross-over bypass.
Intervention typeOther
Primary outcome measureMortality and severe morbidity, measured at 30 days, 3 months, 6 months.
Secondary outcome measures1. Quality of life, measured at 30 days, 3 months, 6 months
2. Length of intensive care stay, measured at 30 days, 3 months, 6 months
3. Cost-effectiveness, measured at 30 days, 3 months, 6 months
Overall study start date05/04/2004
Completion date01/10/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants80 (this was amended on 12/01/2009 to 120 participants)
Key inclusion criteria1. Ruptured aneurysm (diagnosed by computed tomography [CT]-angiography)
2. Anatomical criteria:
2.1. Adequate infrarenal aortic neck
2.2. Adequate iliac anatomy

Added 12/01/2009:
3. Patients greater than 18 years male or female
Key exclusion criteria1. Symptomatic aneurysm (no rupture)
2. Asymptomatic aneurysm
3. Juxtarenal aneurysm
4. Anatomical unsuitability
5. Patient unfit for open procedure
6. Extreme instability of the patient making CT-angiography impossible
Date of first enrolment05/04/2004
Date of final enrolment01/10/2010

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
University/education

Department of Vascular Surgery
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Website http://www.amc.uva.nl
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Charity

Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands) (ref: 2002B197)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article Background, design, methods 01/05/2006 Yes No
Other publications Prospective cohort paper 01/06/2007 Yes No
Results article results 01/08/2013 Yes No
Results article results 01/02/2014 Yes No