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Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices

NCT02407457 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 455

Last updated 2024-10-01

Study results available
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Summary

The objective of this post-market trial is to evaluate Endologix AFX endovascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation. Multiple U.S clinical centers will be involved in the trial to include a broad range of experience. Imaging data will be evaluated by an independent core lab.

Conditions

  • Abdominal Aortic Aneurysm

Interventions

DEVICE

AFX EVAR AAA Graft System

Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.

DEVICE

FDA Approved EVAR AAA Graft Systems

Sponsors & Collaborators

  • Endologix

    lead INDUSTRY

Principal Investigators

  • Christopher Kwolek, MD · Endologix

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-10-31
Completion
2022-10-31
FDA Device
Yes

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 NCT02407457 on ClinicalTrials.gov