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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR85 |
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Date of registration:
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17/06/2005 |
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Primary sponsor: |
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Public title:
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Acute endovascular treatment to improve outcome of ruptured aortoiliac aneurysms.
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Scientific title:
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Acute endovascular treatment to improve outcome of ruptured aortoiliac aneurysms. - the AJAX trial. |
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Date of first enrolment:
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5/4/2004 |
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Target sample size:
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0 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=85 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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R.
Balm |
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Address:
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Academic Medical Center (AMC),
Department of Vascular Surgery G4-111.1,
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5667832 |
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Email:
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r.balm@amc.nl |
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Affiliation:
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Name:
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R.
Balm |
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Address:
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Academic Medical Center (AMC),
Department of Vascular Surgery G4-111.1,
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5667832 |
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Email:
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r.balm@amc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Ruptured aneurysm (diagnosed by CT-angiography);
2. Anatomical criteria:
2.1 Adequate infrarenal aortic neck;
2.2 Adequate iliac anatomy.
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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Ruptured aortic aneurysms, Ruptured aortoiliac aneurysms, Aneurysm
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Intervention(s)
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1. 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 randomized 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 ยง2, artikel 6-1);
2. Open procedure: patient under general anesthesia, laparotomy, standard aortic repair with either an aortic tube graft or a bifurcated graft, standard closure.
3. 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 contra lateral iliac artery, placement of a femoro-femoral cross-over bypass.
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Primary Outcome(s)
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Mortality and severe morbidity.
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Secondary ID(s)
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Dutch Heart Foundation 2002B197
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ISRCTN66212637
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Source(s) of Monetary Support
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Netherlands Heart Foundation (NHS, Nederlandse Hartstichting)
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