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Post-Approval Study of the Ovation™/Ovation Prime™ Abdominal Stent Graft System

NCT01980901 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2021-06-04

No results posted yet for this study

Summary

The Post-Approval Study (PAS) will evaluate the "real world" data on the Ovation™/Ovation Prime™ Abdominal Stent Graft System along with the long-term data collected from the IDE cohort to monitor the long-term safety and effectiveness of the device.

Conditions

  • Aortic Aneurysm, Abdominal

Interventions

DEVICE

Ovation™/Ovation Prime™ Abdominal Stent Graft System

Single occurence permanent implant of AAA device.

Sponsors & Collaborators

  • TriVascular, Inc.

    lead INDUSTRY

Principal Investigators

  • Syed Hussain, MD · Christie Clinical Vein and Vascular Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2020-09-01
Completion
2020-09-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01980901 on ClinicalTrials.gov