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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie vascular healing after mechanical stapler aortic anastomosis in AAA and Leriche Syndrome patients?
How does the Aortic Stapler compare to hand-sewn techniques in AAA and Leriche Syndrome anastomosis outcomes and complication rates?
Which biomarkers predict optimal patient selection for mechanical stapler use in abdominal aortic aneurysm repair and Leriche Syndrome interventions?
What are the potential adverse events of the Aortic Stapler in AAA and Leriche Syndrome surgeries, and how do they differ from standard procedures?
Are there alternative mechanical anastomosis devices or graft materials for AAA and Leriche Syndrome compared to SVSE 2000 Ltd.'s Aortic Stapler?
Trial Locations
- Locations (1)
Augusta Hospital
🇩🇪Duesseldorf, Germany
Augusta Hospital🇩🇪Duesseldorf, Germany