The primary objective of the study is to evaluate the acute safety of deploying and implanting the Altura Endograft in the treatment of AAA in subjects who are candidates for endovascular repair. Secondary objectives are to evaluate the acute and longer-term safety and performance of the Altura Endograft through 5 years.
The primary safety endpoint of the study is freedom from Major Adverse Events (MAE), a composite endpoint consisting of death, stroke, paraplegia, myocardial infarction, respiratory failure, renal failure, bowel ischemia and blood loss ≥ 1000 mL.
Study Type
OBSERVATIONAL
Enrollment
50
Subjects with a documented untreated, unruptured, infrarenal abdominal aorto-iliac aneurysm.
Uniklink
Freiburg im Breisgau, Germany
University Heart Center
Hamburg-Eppendorf, Germany
Park-Krankenhaus Leipzig
Leipzig, Germany
Sankt Bonifatius Hospital
Lingen, Germany
Primary Safety Endpoint
Freedom from Major Adverse Events (MAE), a composite endpoint consisting of: * Death * Stroke * Paraplegia * Myocardial infarction * Respiratory failure * Renal failure * Bowel ischemia * Blood loss ≥ 1000 mL
Time frame: 30 days
Secondary Safety Endpoint
* Major Adverse Events (MAE) * Aneurysm-related death * Type I and III endoleaks * AAA rupture * Re-intervention to correct Type I or Type III endoleaks, migration, occlusion, narrowing, stenosis, kinking or fracture
Time frame: 30 days, 6 and 12 months and annually through 5 years
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