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NCT02407457 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Endologix.

Completed
Registry status
NA
Development phase
455
Enrollment target

NCT02407457: Completed NA study, sponsored by Endologix.

NCT02407457 is a NA study that has completed, run by Endologix. The registered enrollment target is 455 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02407457, a NA study, has completed, sponsored by Endologix.

COMPLETED
Registry status
NA
Development phase
455 participants
Enrollment target

Study 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.

Primary Outcome

ARC is a composite of the most relevant EVAR outcomes and includes: * Peri-Operative Death (\< 30 days) * Rupture * Conversion to OSR * Endoleaks; post-operative * Migration (≥ 10mm) * Aneurysm Enlargement (≥ 5mm) * Endograft Limb Occlusions * Reinterventions for device- or aneurysm-related complications

Interventions

  • DEVICE FDA Approved EVAR AAA Graft Systems
  • DEVICE AFX EVAR AAA Graft System

Trial Details

FieldValue
Enrollment Target 455 participants
Start Date 2015-03
Est. Completion 2022-10
Phase NA
Endologix

17 total trials

What the finished NCT02407457 record still lists

NCT02407457 is an interventional study that assigns participants to a tested intervention. The registered 455 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 2 interventions - of which FDA Approved EVAR AAA Graft Systems is the first listed.

NCT02407457 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02407457 about?

NCT02407457 is a clinical study titled "Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices". 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 w...

What is the current status of trial NCT02407457?

This trial is currently completed. It is a NA study. The enrollment target is 455 participants. The study started on 2015-03. Estimated completion is 2022-10.

What interventions are being tested in trial NCT02407457?

The interventions under investigation include: FDA Approved EVAR AAA Graft Systems (DEVICE), AFX EVAR AAA Graft System (DEVICE).

Who is sponsoring clinical trial NCT02407457?

This trial is sponsored by Endologix, which has 17 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02407457's enrollment target sits among peer trials

455 224th of 2000 higher than 1,777 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02407457, the US trial registry maintained by the National Library of Medicine. NCT02407457 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.