No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
Primary outcome
Mortality and severe morbidity.
Secondary outcome
N/A
Background summary
Participants:
- 3 Hospitals: Academic Medical Center, VU Medical Center and Onze Lieve Vrouwe Gasthuis
- Randomized multicenter trial in the Amsterdam region.
Study objective
Acute endovascular treatment improves outcome of ruptured aortoiliac aneurysms.
Study design
N/A
Intervention
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.
Department of Vascular Surgery G4-111.1,
P.O. Box 22660
R. Balm
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667832
r.balm@amc.nl
Department of Vascular Surgery G4-111.1,
P.O. Box 22660
R. Balm
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667832
r.balm@amc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL55 |
| NTR-old | NTR85 |
| Other | : Dutch Heart Foundation 2002B197 |
| ISRCTN | ISRCTN66212637 |