Abdominal Aortic Aneurysm Clinical Trial
Official title:
LIFE Study: Least Invasive Fast-Track EVAR With the Ovation® Abdominal Stent Graft Platform
The primary objectives of the LIFE Study are to demonstrate the clinical and cost benefits associated with using the Ovation® Abdominal Stent Graft Platform under the least invasive conditions defined in the Fast-Track EVAR protocol. The key elements of the Fast-Track EVAR protocol include: appropriate patient selection, bilateral percutaneous access, no general anesthesia, no ICU admission post procedure, and next day discharge.
The LIFE Study is a prospective, consecutively enrolling, non-randomized multi center post-market registry to evaluate the ultra low profile (14F) Ovation Abdominal Stent Graft Platform when using in the Percutaneous Endovascular Aneurysm Repair (P-EVAR) treatment of patients with AAA using a Fast-Track EVAR protocol. 250 study patients will be enrolled at up to 40 institutions. Follow-up period is one month. ;
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