Geruptureerd aneurysma van de abdominale aorta.
Conditions
Interventions
Het herstellen van de geruptureerde of symptomatisch aneurysma van de abdominale aorta door het inbrengen van de Anaconda bifurcated endograft.
Sponsors
Terumo Vascutek Limited
Newmains Avenue
Renfrewshire PA4 9RR
SCHOTLAND
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged > 18 years; 2. Patient with a ruptured infrarenal AAA*. Rupture is defined as extravasation of blood (haemorrhage outside the aortic wall), documented by: (1) preoperative CT examination, or preoperative ultrasound, or intraoperatively at laparotomy/implant. In the case that after treatment there is still doubt whether the AAA is ruptured, rupture should be confirmed by postoperative CT scan or, in the patient¡¦s death, by autopsy; 3. Patient willing and available to comply with follow up requirements after successful treatment; 4. The subject or legal guardian has been informed of the nature of the study and agrees to its provisions and had provided written informed consent; 5. Infrarenal proximal neck diameter 18 ¡V 31.5mm; 6. Parallel or conical infrarenal neck shape; 7. Infrarenal proximal neck length >15 mm; 8. Distal Iliac fixation site diameter 20 mm in length; 10. Access vessels: appropriate anatomy, at the physician¡¦s discretion.
Exclusion criteria
Exclusion criteria: 1. XJuxta or suprarenal extension of aneurysm; 2. XKnown allergy to contrast medium, nitinol or polyester; 3. XNeed for surgical reconstruction of other visceral arteries; 4. XInfra renal aortic angulation > 90o; 5. XPresence of >= 50% continuous calcification of proximal neck; 6. XPresence of >= 80% thrombus in proximal neck; 7. XPresence of reversed conical infrarenal neck; 8. XOther unsuitable anatomy; 9. XThe patient chooses to be treated by open surgery; 10. XPatients with cancer, with is likely to cause death within one year; 11. Patients not fulfilling the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Operative mortality, defined as death within the first 30 days or after 30 days if occurring the same hospitalization (in-hospital mortality); 2. Three months mortality from all causes; 3. Aneurysm-related death (secondary to AAA rupture or secondary procedures; 4. Effectiveness of exclusion of the AAA; 5. Major morbidity (i.1. serious adverse events); 6. Operation time; 7. Time to reach successful stiff wire cannulation of the contralateral gate. | — |
Contacts
Public ContactA. Stam
Medisch Spectrum Twente Postbus 50000
Outcome results
None listed