Trials / Completed
CompletedNCT00235092
The REALITY Study - Head-to-Head Comparison Between Cypher and Taxus
A Prospective, Randomized, Multi-Center Comparison of the Cypher Sirolimus-Eluting and the Taxus Paclitaxel-Eluting Stent Systems.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,335 (planned)
- Sponsor
- Cordis US Corp. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of this study is to compare the performance of the Cypher sirolimus-eluting and the Taxus paclitaxel-eluting stent systems in a prospective, multi-center, randomized clinical study.
Detailed description
This is a prospective, randomized study conducted at 90 centers in Europe, Latin-America and Asia. A total of 1335 patients will be entered into the study and will be randomized on a 1:1 basis to either the sirolimus-eluting or the paclitaxel-eluting stent system. All patients will have repeat angiography at eight months and will be followed for 24 months post-procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cypher Sirolimus-Eluting Stent | |
| DEVICE | Taxus Paclitaxel-Eluting Stent |
Timeline
- Start date
- 2003-08-01
- Completion
- 2006-03-01
- First posted
- 2005-10-10
- Last updated
- 2007-04-27
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00235092. Inclusion in this directory is not an endorsement.