Evaluation of Mechanical Stapler for Aortic Anastomoses
Not Applicable
- Conditions
- Aortic Aneurysm, AbdominalLeriche Syndrome
- Registration Number
- NCT00319475
- Lead Sponsor
- SVSE 2000 Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Time to complete each stapled anastomosis.
- Secondary Outcome Measures
Name Time Method Post-operative follow up: no leakage no dilatation no fistula or hematoma at the anastomotic sites
Trial Locations
- Locations (1)
Augusta Hospital
🇩🇪Duesseldorf, Germany