Trials / Completed
CompletedNCT00231257
Sirolimus-Eluting Stent vs. Intravascular Brachytherapy in In-Stent Restenotic Coronary Artery Lesions(SISR)
A Multicenter, Randomized Study of the Sirolimus-Eluting Bx VELOCITY® BALLOON Expandable Stent vs. Intravascular Brachytherapy in the Treatment of Patients With In-Stent Restenotic Coronary Artery Lesions
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 384 (actual)
- Sponsor
- Cordis US Corp. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent | Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent |
| PROCEDURE | Brachytherapy | Brachytherapy |
Timeline
- Start date
- 2003-02-01
- Primary completion
- 2005-01-01
- Completion
- 2009-09-01
- First posted
- 2005-10-04
- Last updated
- 2009-11-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00231257. Inclusion in this directory is not an endorsement.