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Acute endovascular treatment to improve outcome of ruptured aortoiliac aneurysms.


- candidate number0
- NTR NumberNTR85
- ISRCTNISRCTN66212637
- Date ISRCTN created12-sep-2005
- date ISRCTN requested15-aug-2005
- Date Registered NTR17-jun-2005
- Secondary IDsDutch Heart Foundation 2002B197 
- Public TitleAcute endovascular treatment to improve outcome of ruptured aortoiliac aneurysms.
- Scientific TitleAcute endovascular treatment to improve outcome of ruptured aortoiliac aneurysms.
- ACRONYMthe AJAX trial.
- hypothesisAcute endovascular treatment improves outcome of ruptured aortoiliac aneurysms.
- Healt Condition(s) or Problem(s) studiedRuptured aortic aneurysms, Ruptured aortoiliac aneurysms, Aneurysm
- Inclusion criteria1. Ruptured aneurysm (diagnosed by CT-angiography);
2. Anatomical criteria:
2.1 Adequate infrarenal aortic neck;
2.2 Adequate iliac anatomy.
- 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 5-apr-2004
- planned closingdate1-okt-2007
- Target number of participants0
- Interventions1. 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 2, 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.
- Primary outcomeMortality and severe morbidity.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web sitehttp://www.amc.nl/index.cfm?sid=324
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. PhD. R. Balm
- CONTACT for SCIENTIFIC QUERIESMD. PhD. R. Balm
- Sponsor/Initiator Academic Medical Center (AMC), Department of Vascular Surgery
- Funding
(Source(s) of Monetary or Material Support)
Dutch Heart Foundation (Nederlandse Hartstichting)
- PublicationsN/A
- Brief summaryParticipants:
- 3 Hospitals: Academic Medical Center, VU Medical Center and Onze Lieve Vrouwe Gasthuis
- Randomized multicenter trial in the Amsterdam region.
- Main changes (audit trail)
- RECORD15-aug-2005 - 5-jan-2010


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