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The Pivotal Study of the Aptus Endovascular AAA Repair System

NCT00507559 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2021-11-03

Study results available
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Summary

A prospective, non-randomized, multi-center clinical study to evaluate the safety and effectiveness of the Aptus Endovascular AAA Repair System compared to an open surgical repair historical control group in the treatment of abdominal aortic aneurysms (AAA).

Conditions

  • Abdominal Aortic Aneurysms (AAA)

Interventions

DEVICE

Aptus Endovascular AAA Repair System

EVAR (endovascular aneurysm repair)

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Ronald M Fairman, M.D · University of Pennsylvania

  • Manish Mehta, M.D · Albany Medical College & Albany Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-03-31
Completion
2014-05-31

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 NCT00507559 on ClinicalTrials.gov