Ruptured Aortic Aneurysm Study with the Aanconda bifurcated endograft. A monocenter, prospective, feasibility pilot study. (RASA)
Completed
- Conditions
- Geruptureerd aneurysma van de abdominale aorta.
- Registration Number
- NL-OMON27520
- Lead Sponsor
- Terumo Vascutek LimitedNewmains AvenueRenfrewshire PA4 9RRSCHOTLAND
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
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;
Exclusion Criteria
1. XJuxta or suprarenal extension of aneurysm;
2. XKnown allergy to contrast medium, nitinol or polyester;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Operative mortality, defined as death within the first 30 days or after 30 days if occurring the same hospitalization (in-hospital mortality);<br /><br>2. Three months mortality from all causes;<br /> <br>3. Aneurysm-related death (secondary to AAA rupture or secondary procedures;<br /><br>4. Effectiveness of exclusion of the AAA;<br /><br>5. Major morbidity (i.1. serious adverse events);<br /><br>6. Operation time;<br /><br>7. Time to reach successful stiff wire cannulation of the contralateral gate.<br>
- Secondary Outcome Measures
Name Time Method