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NCT01419769 · ClinicalTrials.gov registry record · NA

AXIOS Stent & Delivery System Study

A NA study, sponsored by Xlumena.

Completed
Registry status
NA
Development phase
30
Enrollment target

NCT01419769: Completed NA study, sponsored by Xlumena.

NCT01419769 is a NA study that has completed, run by Xlumena. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01419769, a NA study, has completed, sponsored by Xlumena.

COMPLETED
Registry status
NA
Development phase
30 participants
Enrollment target

Study Summary

The Xlumena AXIOS Stent and Delivery System is an investigational device in the USA, and this study is being conducted under an Investigational Device Exemption (IDE) granted by the US Food and Drug Administration (FDA). The study design is prospective, multi-center, non-blinded, single-arm (nonrandomized) study. Up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States. Patients will be followed at (approximately) 30 days and/or 60 days depending upon pseudocyst resolution confirmation, at 1-week post-stent removal,and possibly at 3 and 6 month post-stent removal.

Primary Outcome

Subjects are free of access site-related bleeding requiring transfusion

Interventions

  • DEVICE AXIOS Stent & Delivery System

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2011-08
Est. Completion 2013-04
Phase NA
Xlumena

2 total trials

What the finished NCT01419769 record still lists

NCT01419769 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which AXIOS Stent & Delivery System is the first listed.

NCT01419769 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01419769 about?

NCT01419769 is a clinical study titled "AXIOS Stent & Delivery System Study". The Xlumena AXIOS Stent and Delivery System is an investigational device in the USA, and this study is being conducted under an Investigational Device Exemption (IDE) granted by the US Food and Drug Administration (FDA). The study design is prospective, multi-center, non-blinded, single-arm (nonran...

What is the current status of trial NCT01419769?

This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2011-08. Estimated completion is 2013-04.

What interventions are being tested in trial NCT01419769?

The interventions under investigation include: AXIOS Stent & Delivery System (DEVICE).

Who is sponsoring clinical trial NCT01419769?

This trial is sponsored by Xlumena, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01419769's enrollment target sits among peer trials

30 1593rd of 2000 higher than 299 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 NCT01419769, the US trial registry maintained by the National Library of Medicine. NCT01419769 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.