NCT02224794

LIFE Study: Least Invasive Fast-Track EVAR

LIFE Study: Least Invasive Fast-Track EVAR With the Ovation® Abdominal Stent Graft Platform

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: TriVascular, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Abdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	Ovation® Abdominal Stent Graft Platform

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2014-08-25
• Last updated: 2021-06-08

Locations

2 sites across 1 country: United States