| - candidate number | 0 |
| - NTR Number | NTR85 |
| - ISRCTN | ISRCTN66212637 |
| - Date ISRCTN created | 12-sep-2005 |
| - date ISRCTN requested | 15-aug-2005 |
| - Date Registered NTR | 17-jun-2005 |
| - Secondary IDs | Dutch Heart Foundation 2002B197 |
| - Public Title | Acute endovascular treatment to improve outcome of ruptured aortoiliac aneurysms. |
| - Scientific Title | Acute endovascular treatment to improve outcome of ruptured aortoiliac aneurysms. |
| - ACRONYM | the AJAX trial. |
| - hypothesis | Acute endovascular treatment improves outcome of ruptured aortoiliac aneurysms. |
| - Healt Condition(s) or Problem(s) studied | Ruptured aortic aneurysms, Ruptured aortoiliac aneurysms, Aneurysm |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Single |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 5-apr-2004 |
| - planned closingdate | 1-okt-2007 |
| - Target number of participants | 0 |
| - Interventions | 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 §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 outcome | Mortality and severe morbidity. |
| - Secondary outcome | N/A |
| - Timepoints | N/A |
| - Trial web site | http://www.amc.nl/index.cfm?sid=324 |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | MD. PhD. R. Balm |
| - CONTACT for SCIENTIFIC QUERIES | MD. PhD. R. Balm |
| - Sponsor/Initiator | Academic Medical Center (AMC), Department of Vascular Surgery |
| - Funding (Source(s) of Monetary or Material Support) | Netherlands Heart Foundation (NHS, Nederlandse Hartstichting) |
| - Publications | N/A |
| - Brief summary | Participants: - 3 Hospitals: Academic Medical Center, VU Medical Center and Onze Lieve Vrouwe Gasthuis - Randomized multicenter trial in the Amsterdam region. |
| - Main changes (audit trail) | |
| - RECORD | 15-aug-2005 - 5-jan-2010 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl
- Dit zijn de gegevens waarmee uw trial is aangemeld en geregistreerd in het Nederlands Trial Register