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NCT03193619 · ClinicalTrials.gov registry record

Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon

A clinical trial, sponsored by C. R. Bard.

Completed
Registry status
350
Enrollment target

NCT03193619: Completed study, sponsored by C. R. Bard.

NCT03193619 is a clinical trial that has completed, run by C. R. Bard. The registered enrollment target is 350 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03193619 has completed, sponsored by C. R. Bard.

COMPLETED
Registry status
350 participants
Enrollment target

Study Summary

The objective of this study is to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon in a heterogeneous patient population in a real world, on-label clinical application.

Primary Outcome

Optimal result is defined as ≤30% residual stenosis without major flow-limiting dissection, as measured by angiographic imaging. Major flow limiting dissections are classified by the National Heart, Lung, and Blood Institute (NHLBI) as Grade D (Spiral luminal filling defects), Grade E (Appearance of new and persistent filling defects with reduced flow), and Grade F (Total occlusion without distal flow).

Interventions

  • DEVICE PTA (UltraScore Focused Force PTA Balloon)

Trial Details

FieldValue
Enrollment Target 350 participants
Start Date 2018-03-28
Est. Completion 2022-04-01
C. R. Bard

75 total trials

What the finished NCT03193619 record still lists

NCT03193619 is an observational study that tracks outcomes without assigning an intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which PTA (UltraScore Focused Force PTA Balloon) is the first listed.

NCT03193619 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03193619 about?

NCT03193619 is a clinical study titled "Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon". The objective of this study is to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon in a heterogeneous patient population in a real world, on-label clinical application.

What is the current status of trial NCT03193619?

This trial is currently completed. The enrollment target is 350 participants. The study started on 2018-03-28. Estimated completion is 2022-04-01.

What interventions are being tested in trial NCT03193619?

The interventions under investigation include: PTA (UltraScore Focused Force PTA Balloon) (DEVICE).

Who is sponsoring clinical trial NCT03193619?

This trial is sponsored by C. R. Bard, which has 75 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03193619, the US trial registry maintained by the National Library of Medicine. NCT03193619 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.