Addressing Long Lesions, Small Vessels*
For the complete TAXUS V US Randomized
de novo lesion trial data in portable document format (PDF),
click here.
US Randomized de novo Lesion
Pivotal Expansion Trial
| Objective: |
Demonstrate superior 9-month target vessel revascularization (TVR) rate for TAXUS® Express2™ Paclitaxel-Eluting SR Stent vs. Express2™ Stent for de novo lesions. |
| Number of Patients: |
1172 |
| Number of Sites: |
66 |
| Lesion Type: |
de novo, 10-46 mm |
| Stent Platform: |
Express2 8, 16, 24 and 32 mm lengths, 2.25**, 2.5, 3.0, 3.5 and 4.0* mm diameters |
| Release Kinetics: |
Slow |
| Primary Endpoint: |
9-month TVR |
| P.I. and Co-P.I.: |
G.W. Stone, M.D. and S. Ellis, M.D. |
| Status: |
Enrollment Complete |
*Control for TAXUS V de novo is the Express Stent
**Caution: Investigational device limited by United States law to investigational use.
Caution: The safety and effectiveness of the TAXUS Express² Stent have not been established in patients with coronary artery reference diameters less than 2.5 mm or greater than 3.75 mm, in patients with diabetes, or with multiple overlapping stents.
RELATED LINKS:
TAXUS® Express2™ Paclitaxel-Eluting Coronary Stent System Device Information