Evaluation of Mechanical Stapler for Aortic Anastomoses
This trial is active, not recruiting.
|Conditions||aortic aneurysm, abdominal, leriche syndrome|
|Treatment||aaa or af/ib (end-to-end) in patients with leriche syndrome|
|Sponsor||SVSE 2000 Ltd.|
|Start date||February 2006|
|End date||July 2006|
|Trial size||10 participants|
|Trial identifier||NCT00319475, EU-DE 006|
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
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Time to complete each stapled anastomosis.
Post-operative follow up:
no fistula or hematoma at the anastomotic sites
Male or female participants from 21 years up to 85 years old.
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
|Official title||Evaluation of Mechanical Stapler for Aortic Anastomoses|
|Principal investigator||Ralf Kolvenbach, MD|
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