Status:
UNKNOWN
Evaluation of Mechanical Stapler for Aortic Anastomoses
Lead Sponsor:
SVSE 2000 Ltd.
Conditions:
Aortic Aneurysm, Abdominal
Leriche Syndrome
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
Demonstrate the safety and performance of the Aortic Stapler when used to attach a synthetic graft to an aorta in AAA and Leriche Syndrome patients
Eligibility Criteria
Inclusion
- Patient age is between 21 to 85 years old.
- Patient is diagnosed with Abdominal Aortic Aneurysm (AAA) or -aorto-Iliac/Femoral Occlusive Arterial Disease (Leriche' syndrome) by CT-Angio examination and/or angiography examination in patients with Leriche' syndrome.
- Patient with an aneurysm at the neck of the proximal or distal site that is between 5 to 10 mm and with a diameter of 16-22 mm.
- Patient is scheduled for AAA repair
Exclusion
- Pregnant women
- Active malignancy
- Ruptured aneurysm
- Thoraco-AAA
- Patient with at least one of the following unstable risk factors:
- Renal disease (Cr \>2)
- Ischemic heart disease (unstable Angina)
- Obstructive Pulmonary Disease (contraindicated for open aortic surgery by respiratory function exam)
- Severe CHF (EF \< 25%)
- Patient with known allergy to metals or to the contrast media
- Participation in current or recent (within 60 days prior to surgery) clinical trial
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00319475
Start Date
February 1 2006
End Date
July 1 2006
Last Update
October 11 2006
Active Locations (1)
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1
Augusta Hospital
Düsseldorf, Germany, 40472