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NCT01937351 · ClinicalTrials.gov registry record · NA

Evaluation of the Pantheris Atherectomy System

A NA study, sponsored by Avinger.

Completed
Registry status
NA
Development phase
162
Enrollment target

NCT01937351: Completed NA study, sponsored by Avinger.

NCT01937351 is a NA study that has completed, run by Avinger. The registered enrollment target is 162 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01937351, a NA study, has completed, sponsored by Avinger.

COMPLETED
Registry status
NA
Development phase
162 participants
Enrollment target

Study Summary

A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an atherectomy device that provides directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque in diseased lower extremity arteries.

Primary Outcome

The primary safety endpoint is defined as freedom from a composite of major adverse events (MAE) through 6-Month follow-up as adjudicated by an independent Clinical Events Committee (CEC). Individual MAEs include: 1. Cardiovascular related death 2. Unplanned, major index limb amputation 3. Clinically driven target lesion revascularization (TLR) 4. Myocardial infarction 5. Device related events: 1. Clinically significant perforation 2. Clinically significant dissection 3. Clinically si

Interventions

  • DEVICE Pantheris System

Trial Details

FieldValue
Enrollment Target 162 participants
Start Date 2013-06-25
Est. Completion 2015-09-20
Phase NA
Avinger

6 total trials

What the finished NCT01937351 record still lists

NCT01937351 is an interventional study that assigns participants to a tested intervention. The registered 162 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 (88% lower).

The record links to 0 conditions, and to 1 intervention - of which Pantheris System is the first listed.

NCT01937351 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01937351 about?

NCT01937351 is a clinical study titled "Evaluation of the Pantheris Atherectomy System". A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an atherectomy device that provides directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque in diseased lower extremity arteries.

What is the current status of trial NCT01937351?

This trial is currently completed. It is a NA study. The enrollment target is 162 participants. The study started on 2013-06-25. Estimated completion is 2015-09-20.

What interventions are being tested in trial NCT01937351?

The interventions under investigation include: Pantheris System (DEVICE).

Who is sponsoring clinical trial NCT01937351?

This trial is sponsored by Avinger, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01937351's enrollment target sits among peer trials

162 627th of 2000 higher than 1,373 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 NCT01937351, the US trial registry maintained by the National Library of Medicine. NCT01937351 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.