The REALITY Study - Head-to-Head Comparison Between Cypher and Taxus
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.
Coronary Artery Disease
Device: Cypher Sirolimus-Eluting Stent
Device: Taxus Paclitaxel-Eluting Stent
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized, Multi-Center Comparison of the Cypher Sirolimus-Eluting and the Taxus Paclitaxel-Eluting Stent Systems.|
- The primary endpoint of the study is angiographic in-lesion binary restenosis rate at 8 months follow-up as determined by QCA.
|Study Start Date:||August 2003|
|Estimated Study Completion Date:||March 2006|
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.