The purpose of this study is to evaluate the safety of deploying and implanting the Altura Abdominal Aortic Aneurysm (AAA) Endograft in the treatment of abdominal aortic aneurysms in subjects who are candidates for open surgical aneurysm repair.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Altura Medical AAA Stent Graft System
Pontificia Universidad Catolica De Chile
Santiago, Chile
Stradins University Hospital
Riga, Latvia
The rate of major adverse events.
Adverse events defined as the composite endpoint of death, significant blood loss requiring intervention, respiratory failure, myocardial infarction, renal failure, paralysis, stroke, bowel ischemia and/or device migration causing vascular compromise.
Time frame: 30 days
Feasibility of device defined by clinical and technical success
Evaluate the feasibility of using Altura AAA Endograft. Feasibility is comprised of acute clinical and technical success measured at the time of procedure. Long-term safety will be evaluated at 6 months, 1 year and 2 years.
Time frame: 6 months, 1 year and 2 years
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