Addressing In-Stent Restenosis*
For the complete TAXUS V US Randomized Pivotal ISR trial data in portable document format (PDF),
click here.
US Randomized Pivotal ISR Trial
| Objective: |
To demonstrate superior or non-inferior 9-month target vessel revascularization (TVR) rate for TAXUS® Express2™ Paclitaxel-Eluting SR Stent compared to intra-coronary brachytherapy. |
| Number of Patients: |
396 |
| Number of Sites: |
37 |
| Lesion Type: |
ISR of previously implanted stent; length <46 mm |
| Stent Platform: |
Express2 8, 16, 20, 24, and 32 mm lengths, 2.25, 2.5, 3.0, 3.5, and 4.0 mm diameters |
| Release Kinetics: |
Slow Release |
| Primary Endpoint: |
9-month TVR |
| P.I. and Co-P.I.: |
G.W. Stone, M.D. and S. Ellis, M.D. |
| Status: |
Enrollment Complete
|
The safety and effectiveness of the TAXUS Express
2 Stent have not been established in patients with coronary artery reference diameter less than 2.5 mm or in lesions longer than 28 mm or in patients with diabetes.
Caution: The safety and efficacy of the TAXUS Express
2 Stent have not been established for the treatment of in-stent restenosis.
RELATED LINKS:
TAXUS® Express2™ Paclitaxel-Eluting Coronary Stent System Device Information
