Condition category
Circulatory System
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
19/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.amc.nl/index.cfm?sid=324

Contact information

Type

Scientific

Primary contact

Dr R Balm

ORCID ID

Contact details

Academic Medical Centre
Department of Vascular Surgery G4-111.1
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5667832
r.balm@amc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR85; 2002B197

Study information

Scientific title

Acronym

AJAX

Study hypothesis

Acute 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

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information material can be found at: http://www.amc.nl/index.cfm?pid=1132 (in Dutch only)

Condition

Ruptured aorto-iliac aneurysms

Intervention

CT 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Mortality and severe morbidity, measured at 30 days, 3 months, 6 months.

Secondary outcome measures

1. 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 trial start date

05/04/2004

Overall trial end date

01/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80 (this was amended on 12/01/2009 to 120 participants)

Participant exclusion criteria

1. 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

Recruitment start date

05/04/2004

Recruitment end date

01/10/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Department of Vascular Surgery
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

http://www.amc.uva.nl

Funders

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Background, design, methods on http://www.ncbi.nlm.nih.gov/pubmed/16956484
2. Prospective cohort paper on http://www.ncbi.nlm.nih.gov/pubmed/17276096
3. 2013 results in http://journals.lww.com/annalsofsurgery/Abstract/publishahead/Endovascular_Repair_Versus_Open_Repair_of_Ruptured.98466.aspx
4. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24469619

Publication citations

  1. Prospective cohort paper

    Hoornweg LL, Wisselink W, Vahl A, Balm R, , The Amsterdam Acute Aneurysm Trial: suitability and application rate for endovascular repair of ruptured abdominal aortic aneurysms., Eur J Vasc Endovasc Surg, 2007, 33, 6, 679-683, doi: 10.1016/j.ejvs.2006.12.011.

  2. Results

    Kapma MR, Dijksman LM, Reimerink JJ, de Groof AJ, Zeebregts CJ, Wisselink W, Balm R, Dijkgraaf MG, Vahl AC, Cost-effectiveness and cost-utility of endovascular versus open repair of ruptured abdominal aortic aneurysm in the Amsterdam Acute Aneurysm Trial., Br J Surg, 2014, 101, 3, 208-215, doi: 10.1002/bjs.9356.

  3. Amsterdam Acute Aneurysm trial: background, design, and methods., Vascular, 14, 3, 130-135.

Additional files

Editorial Notes