Standard EVAR Group for Abdominal Aortic Aneurysm

N/A

Waitlist Available

Led By Zvonimir Krajcer, MD

Research Sponsored by TriVascular, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Abdominal Aortic Aneurysm

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Standard P-EVAR GroupExperimental Treatment1 Intervention

includes subjects who do not complete the Fast-Track EVAR protocol, and their procedures are completed with bilateral percutaneous access

Group II: Standard EVAR GroupExperimental Treatment1 Intervention

includes subjects who do not complete the Fast-Track EVAR protocol, and their procedures are not completed with bilateral percutaneous access (i.e. converted to femoral cutdown or open surgical repair)

Group III: Fast-Track GroupExperimental Treatment1 Intervention

includes subjects who complete the Fast-Track EVAR protocol

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ovation® Abdominal Stent Graft Platform

2014

N/A

~250

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