Aortic Aneurysm, Abdominal, Leriche Syndrome
Conditions
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
Interventions
PROCEDUREAAA or AF/IB (end-to-end) in patients with Leriche Syndrome
Sponsors
SVSE 2000 Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to complete each stapled anastomosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-operative follow up: | — |
| no leakage | — |
| no dilatation | — |
| no fistula or hematoma at the anastomotic sites | — |
Countries
Germany
Outcome results
None listed