No registrations found.
ID
Source
Brief title
Health condition
Geruptureerd aneurysma van de abdominale aorta.
Sponsors and support
Newmains Avenue
Renfrewshire PA4 9RR
SCHOTLAND
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
N/A
Background summary
N/A
Study objective
The prupose if this study is; to accesss the feasibility of treatment of rAAA with a bifurcated endograft with the magnetic wire system to speed up the contralateral gate access.
Study design
N/A
Intervention
Het herstellen van de geruptureerde of symptomatisch aneurysma van de abdominale aorta door het inbrengen van de Anaconda bifurcated endograft.
Postbus 50000
A. Stam
Enschede 7500 KA
The Netherlands
researchbureau.heelkunde@ziekenhuis-mst.nl
Postbus 50000
A. Stam
Enschede 7500 KA
The Netherlands
researchbureau.heelkunde@ziekenhuis-mst.nl
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 < 17 mm;
9. Distal Iliac fixation site > 20 mm in length;
10. Access vessels: appropriate anatomy, at the physician¡¦s discretion.
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
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 | NL633 |
| NTR-old | NTR693 |
| Other | : N/A |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |