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NCT00231257 · ClinicalTrials.gov registry record · Phase 3

Sirolimus-Eluting Stent vs. Intravascular Brachytherapy in In-Stent Restenotic Coronary Artery Lesions(SISR)

A Phase 3 study, sponsored by Cordis US.

Completed
Registry status
Phase 3
Development phase
384
Enrollment target

NCT00231257: Completed Phase 3 study, sponsored by Cordis US.

NCT00231257 is a Phase 3 study that has completed, run by Cordis US. The registered enrollment target is 384 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00231257, a Phase 3 study, has completed, sponsored by Cordis US.

COMPLETED
Registry status
Phase 3
Development phase
384 participants
Enrollment target

Study Summary

The main objective of this study is to demonstrate the superiority or non-inferiority of the sirolimus-eluting Bx VELOCITY® stent compared to intravascular brachytherapy in patients with in-stent restenotic native coronary artery lesions.

Interventions

  • DEVICE Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent
  • PROCEDURE Brachytherapy

Trial Details

FieldValue
Enrollment Target 384 participants
Start Date 2003-02
Est. Completion 2009-09
Phase Phase 3
Cordis US

19 total trials

What the finished NCT00231257 record still lists

NCT00231257 is an interventional study that assigns participants to a tested intervention. The registered 384 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 2 interventions - of which Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent is the first listed.

NCT00231257 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00231257 about?

NCT00231257 is a clinical study titled "Sirolimus-Eluting Stent vs. Intravascular Brachytherapy in In-Stent Restenotic Coronary Artery Lesions(SISR)". The main objective of this study is to demonstrate the superiority or non-inferiority of the sirolimus-eluting Bx VELOCITY® stent compared to intravascular brachytherapy in patients with in-stent restenotic native coronary artery lesions.

What is the current status of trial NCT00231257?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 384 participants. The study started on 2003-02. Estimated completion is 2009-09.

What interventions are being tested in trial NCT00231257?

The interventions under investigation include: Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent (DEVICE), Brachytherapy (PROCEDURE).

Who is sponsoring clinical trial NCT00231257?

This trial is sponsored by Cordis US, which has 19 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00231257's enrollment target sits among peer trials

384 975th of 2000 higher than 1,025 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00231257, the US trial registry maintained by the National Library of Medicine. NCT00231257 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.