Evaluation of Mechanical Stapler for Aortic Anastomoses

SVSE 2000

Status

Unknown

Conditions

Aortic Aneurysm, Abdominal

Leriche Syndrome

Treatments

Procedure: AAA or AF/IB (end-to-end) in patients with Leriche Syndrome

Study type

Interventional

Funder types

Industry

Identifiers

EU-DE 006

Details and patient eligibility

About

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

Sex

All

Ages

21 to 85 years old

Volunteers

No Healthy Volunteers

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