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Stent Graft

Clinical Study of the TriVascular Ovation™ Abdominal Stent Graft System

N/A
Waitlist Available
Led By Manish Mehta, MD
Research Sponsored by TriVascular, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Inclusion/
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

The primary objectives of this study are to determine whether the Ovation Abdominal Stent Graft System is a safe and effective method of treating abdominal aortic aneurysms (AAA's) in those patients considered to be suitable candidates for open surgical repair.

Eligible Conditions
  • Abdominal Aortic Aneurysm

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The Primary Effectiveness Endpoint is Percentage of Subjects That Achieve Treatment Success.
The Primary Safety Endpoint is Defined as the Percentage of Subjects Who Experience a Major Adverse Event Within 30 Days of the Initial Procedure.
Secondary study objectives
Composite Safety and Effectiveness Endpoints

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ovation™ Abdominal Stent Graft SystemExperimental Treatment1 Intervention
Implant of Ovation™ Abdominal Stent Graft System
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ovation™ Abdominal Stent Graft System
2010
N/A
~170

Find a Location

Who is running the clinical trial?

TriVascular, Inc.Lead Sponsor
9 Previous Clinical Trials
1,398 Total Patients Enrolled
Manish Mehta, MDPrincipal InvestigatorAlbany Medical College
1 Previous Clinical Trials
379 Total Patients Enrolled
~10 spots leftby Jan 2026
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