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van CCT (UK)

van CCT (UK)

Ruptured Aortic Aneurysm Study with the Aanconda bifurcated endograft. A monocenter, prospective, feasibility pilot study. (RASA)

- candidate number2105
- NTR NumberNTR693
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-mei-2006
- Secondary IDsN/A 
- Public TitleRuptured Aortic Aneurysm Study with the Aanconda bifurcated endograft. A monocenter, prospective, feasibility pilot study. (RASA)
- Scientific TitleRuptured Aortic Aneurysm Study with the Aanconda bifurcated endograft. A monocenter, prospective, feasibility pilot study.
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedAneurysm
- Inclusion criteria1. 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 patientˇ¦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 ˇV 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 physicianˇ¦s discretion.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 23-feb-2006
- planned closingdate1-mrt-2007
- Target number of participants5
- InterventionsHet herstellen van de geruptureerde of symptomatisch aneurysma van de abdominale aorta door het inbrengen van de Anaconda bifurcated endograft.
- Primary outcome1. 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 outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD29-mei-2006 - 16-nov-2009

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