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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 is a Phase 3 study that has completed, run by Cordis US. The registered enrollment target is 384 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 384 participants |
| Start Date | 2003-02 |
| Est. Completion | 2009-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00231257
The ClinicalTrials.gov registry entry for NCT00231257 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 384 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cordis US, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent is the first listed.
NCT00231257 reports 0 study locations.
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.
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