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NCT01938391 · ClinicalTrials.gov registry record · NA

Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

A NA study, sponsored by Abbott Medical Devices.

Completed
Registry status
NA
Development phase
25
Enrollment target

NCT01938391: Completed NA study, sponsored by Abbott Medical Devices.

NCT01938391 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 25 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

NCT01938391, a NA study, has completed, sponsored by Abbott Medical Devices.

COMPLETED
Registry status
NA
Development phase
25 participants
Enrollment target

Study Summary

IVUS imaging will be utilized to assess performance of the Sponsor's Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) in patients who have symptomatic peripheral artery disease (PAD) occurring in the Superficial Femoral Artery (SFA), Popliteal (POP), and/or Tibioperoneal Trunk (TPT).

Primary Outcome

A Kaplan-Meier analysis was performed to determine the percent probability that a study participant had a TLR at 6 months and at 12 months.

Interventions

  • DEVICE Stealth 360°® OAS

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2013-01
Est. Completion 2015-02
Phase NA
Abbott Medical Devices

261 total trials

What the finished NCT01938391 record still lists

NCT01938391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 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 Stealth 360°® OAS is the first listed.

NCT01938391 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01938391 about?

NCT01938391 is a clinical study titled "Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal". IVUS imaging will be utilized to assess performance of the Sponsor's Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) in patients who have symptomatic peripheral artery disease (PAD) occurring in the Superficial Femoral Artery (SFA), Popliteal (POP), and/or Tibioperon...

What is the current status of trial NCT01938391?

This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2013-01. Estimated completion is 2015-02.

What interventions are being tested in trial NCT01938391?

The interventions under investigation include: Stealth 360°® OAS (DEVICE).

Who is sponsoring clinical trial NCT01938391?

This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01938391's enrollment target sits among peer trials

25 1712th of 2000 higher than 265 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 NCT01938391, the US trial registry maintained by the National Library of Medicine. NCT01938391 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.