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NCT00232765 · ClinicalTrials.gov registry record · Phase 3

Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions (SIRIUS)

A Phase 3 study of Coronary Artery Disease, sponsored by Cordis US.

Completed
Registry status
Phase 3
Development phase
1,058
Enrollment target
1
Study location

NCT00232765 is a Phase 3 study of Coronary Artery Disease that has completed, run by Cordis US. The registered enrollment target is 1,058 participants, below the 1,282-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00232765, a Phase 3 study of Coronary Artery Disease, has completed, sponsored by Cordis US.

COMPLETED
Registry status
Phase 3
Development phase
1,058 participants
Enrollment target
1
Study location

Study Summary

The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITYTM stent in reducing target vessel failure in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITYTM balloon-expandable stent. Both stents are mounted on the Raptorâ over-the-wire (OTW) Stent Delivery System.

Conditions Studied

Interventions

  • DEVICE CYPHER Sirolimus-Eluting Stent
  • DEVICE Uncoated BX VELOCITY Balloon-Expandable Stent

Study Locations (1)

New York

  • New York Presbyterian Hospital/Columbia University Medical Center - New York

Trial Details

FieldValue
Enrollment Target 1,058 participants
Start Date 2001-02
Est. Completion 2008-11
Phase Phase 3

Sponsor

Cordis US

19 total trials

What the Registry Record Tells You About NCT00232765

The ClinicalTrials.gov registry entry for NCT00232765 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,058 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,282-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (17% lower). The listed sponsor is Cordis US, which has 19 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which CYPHER Sirolimus-Eluting Stent is the first listed.

NCT00232765 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT00232765 about?

NCT00232765 is a clinical study titled "Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions (SIRIUS)". The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITYTM stent in reducing target vessel failure in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITYTM balloon-expandable stent. Both stents are mounted on the Raptor...

What is the current status of trial NCT00232765?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,058 participants. The study started on 2001-02. Estimated completion is 2008-11.

What conditions does trial NCT00232765 study?

This clinical trial studies the following conditions: Coronary Artery Disease.

What interventions are being tested in trial NCT00232765?

The interventions under investigation include: CYPHER Sirolimus-Eluting Stent (DEVICE), Uncoated BX VELOCITY Balloon-Expandable Stent (DEVICE).

Who is sponsoring clinical trial NCT00232765?

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

Where is trial NCT00232765 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.