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.
Study Type
OBSERVATIONAL
Enrollment
250
Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States
St. Luke's Episcopal Hospital
Houston, Texas, United States
Major Adverse Events
Time frame: 30 days
Serious and non-serious adverse events, including vascular and major access site vascular complications
Time frame: 30 days
Assess technical success, defined as percent of procedures successfully completed with bilateral percutaneous access
Time frame: 30 days
Treatment success, defined as percent of subjects who successfully follow least invasive protocol through discharge
Time frame: 30 days
Blood loss, including if transfusion required
Time frame: 30 days
Percent of procedures completed without general anesthesia
Time frame: 30 days
Anesthesia time
Time frame: 30 days
Procedure time
Time frame: 30 days
Contrast volume
Time frame: 30 days
Fluoroscopy time
Time frame: 30 days
Time to hemostasis
Time frame: 30 days
Time to ambulation
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time to normal diet
Time frame: 30 days
Groin pain
Time frame: 30 days
Quality of Life
Time frame: 30 days
Percent of subjects discharged without ICU admission
Time frame: 30 days
Length of ICU stay, if required
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
Percent of subjects discharged within only one midnight stay
Time frame: 30 days
Freedom from type I and III endoleaks
Time frame: 30 days
Freedom from AAA rupture
Time frame: 30 days
Freedom from conversion to open repair
Time frame: 30 days
Freedom from AAA related secondary interventions
Time frame: 30 days
Freedom from mortality
Time frame: 30 days