Acute endovascular treatment to improve outcome of ruptured aorto-iliac aneurysms
ISRCTN | ISRCTN66212637 |
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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
Contact information
Dr R Balm
Scientific
Scientific
Academic Medical Centre
Department of Vascular Surgery G4-111.1
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Phone | +31 (0)20 5667832 |
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r.balm@amc.nl |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Patient information material can be found at: http://www.amc.nl/index.cfm?pid=1132 (in Dutch only) |
Scientific title | |
Study acronym | AJAX |
Study objectives | 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(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) studied | 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 |
Primary outcome measure | 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 study start date | 05/04/2004 |
Completion date | 01/10/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 80 (this was amended on 12/01/2009 to 120 participants) |
Key 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 |
Key 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 |
Date of first enrolment | 05/04/2004 |
Date of final enrolment | 01/10/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
University/education
University/education
Department of Vascular Surgery
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Website | http://www.amc.uva.nl |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |