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.
ID
Bron
Verkorte titel
Aandoening
Geruptureerd aneurysma van de abdominale aorta.
Ondersteuning
Newmains Avenue
Renfrewshire PA4 9RR
SCHOTLAND
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Operative mortality, defined as death within the first 30 days or after 30 days if occurring the same hospitalization (in-hospital mortality);<br>
2. Three months mortality from all causes;<br>
3. Aneurysm-related death (secondary to AAA rupture or secondary procedures;<br>
4. Effectiveness of exclusion of the AAA;<br>
5. Major morbidity (i.1. serious adverse events);<br>
6. Operation time;<br>
7. Time to reach successful stiff wire cannulation of the contralateral gate.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Het herstellen van de geruptureerde of symptomatisch aneurysma van de abdominale aorta door het inbrengen van de Anaconda bifurcated endograft.
Publiek
Postbus 50000
A. Stam
Enschede 7500 KA
The Netherlands
researchbureau.heelkunde@ziekenhuis-mst.nl
Wetenschappelijk
Postbus 50000
A. Stam
Enschede 7500 KA
The Netherlands
researchbureau.heelkunde@ziekenhuis-mst.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL633 |
| NTR-old | NTR693 |
| Ander register | : N/A |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |