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NCT02063672 · ClinicalTrials.gov registry record · NA

Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis

A NA study, sponsored by C. R. Bard.

Completed
Registry status
NA
Development phase
82
Enrollment target

NCT02063672: Completed NA study, sponsored by C. R. Bard.

NCT02063672 is a NA study that has completed, run by C. R. Bard. The registered enrollment target is 82 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02063672, a NA study, has completed, sponsored by C. R. Bard.

COMPLETED
Registry status
NA
Development phase
82 participants
Enrollment target

Study Summary

To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).

Primary Outcome

Primary patency is defined as freedom from clinically driven target lesion restenosis (TLR) and from Binary Restenosis.

Interventions

  • DEVICE Lutonix DCB
  • DEVICE Standard Uncoated Balloon Angioplasty Catheter

Trial Details

FieldValue
Enrollment Target 82 participants
Start Date 2014-03
Est. Completion 2019-03
Phase NA
C. R. Bard

75 total trials

What the finished NCT02063672 record still lists

NCT02063672 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which Lutonix DCB is the first listed.

NCT02063672 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02063672 about?

NCT02063672 is a clinical study titled "Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis". To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).

What is the current status of trial NCT02063672?

This trial is currently completed. It is a NA study. The enrollment target is 82 participants. The study started on 2014-03. Estimated completion is 2019-03.

What interventions are being tested in trial NCT02063672?

The interventions under investigation include: Lutonix DCB (DEVICE), Standard Uncoated Balloon Angioplasty Catheter (DEVICE).

Who is sponsoring clinical trial NCT02063672?

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

How this trial's enrollment target compares

Where NCT02063672's enrollment target sits among peer trials

82 990th of 2000 higher than 1,009 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 NCT02063672, the US trial registry maintained by the National Library of Medicine. NCT02063672 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.