|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P060008 S011/ PAS001 |
| Date Original Protocol Accepted |
07/23/2010
|
| Date Current Protocol Accepted |
07/23/2010
|
| Study Name |
TAXUS Long (S011)
|
| Device Name |
TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, multi-center study designed to observe clinical outcomes in patients receiving the TAXUS Liberte-Paclitaxel-Eluting Coronary Stent and prasugrel as part of a dual antiplatelet therapy drug regimen. This is a consecutively-enrolled study with follow-up through 5 years. This study will also contribute patient data to an FDA-requested and industry-sponsored research study that will evaluate the optimal duration of dual antiplatelet therapy study.
|
| Study Population |
The TAXUS Liberté Long Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface. The stent is mounted over a deflated balloon attached to the end of a long thin flexible tube called a stent delivery catheter. The stent is indicated for improving luminal diameter for the treatment of de novo lesions in native coronary arteries >=2.75 mm to <=4. 00 mm in diameter in lesions <=34 mm in length.
|
| Sample Size |
84 subjects, 100 sites
|
| Key Study Endpoints |
Data will be collected on the rate of cardiac death or myocardial infarction through 12 months. This will be compared with the cardiac death or myocardial infarction rates observed through 12 months in control arm of the TAXUS ATLAS Workhorse Clinical Trial and the ARRIVE 1 and 2 registries.
|
| Follow-up Visits and Length of Follow-up |
Patient follow up will occur at months 6, 12, 15, 18, 24, 30, 33, 36, 48 and 60 post index procedure, for all enrolled patients. Follow-up for months 15, 33, 36, 48 and 60 may be conducted via telephone. Follow-up for months 6, 12, 18, 24 and 30 must be conducted during a clinical visit for the purposes of study drug dispensing and accountability. The 18-month office visit is intended to serve the purposes of drug dispensing and accountability only.
|
| Interim or Final Data Summary |
| Interim Results |
The study has recently started, no results available.
|
| Actual Number of Patients Enrolled |
150
|
| Actual Number of Sites Enrolled |
24
|
| Patient Follow-up Rate |
90.2%
|
| Final Safety Findings |
¿MACE: out-of-hospital MACE to 5 years was comparable for the groups (32.6% for the TAXUS® ATLAS Group and 27.6% for the Control Group, P=0.3790).
¿Stent Thrombosis: Stent thrombosis rates were not statistically different for the TAXUS® ATLAS Group versus the Control Group (2.5% versus 0.9%, P=0.6220)
¿All Death: Rates through 5 years were comparable between the TAXUS® ATLAS Group and the Control Group (11.1% versus 10.9%, P=0.9465).
¿Non-cardiac Death: Rates through 5 years were not statistically different the TAXUS® ATLAS Group and the Control Group (7.0% versus 2.5%, P=0.1054).
|
| Final Effect Findings |
¿MACE (cardiac death, MI, and TVR): The rate at 5 years was comparable between the TAXUS® ATLAS Group and the Control Group (32.6% versus 30.7%, respectively).
¿Cardiac Death: Rates through 5 years were comparable for the TAXUS® ATLAS Group and the Control Group (4.5% versus 8.7%).
¿MI: Rates through 5 years were comparable for the TAXUS® ATLAS Group and the Control Group (7.6% versus 11.8%).
¿TVR: The rate at 5 years was comparable for the TAXUS® ATLAS Group versus the Control Group (25.8% versus 20.5%).
¿TLR: The rate at 5 years was comparable for the TAXUS® ATLAS Group versus the Control Group (18.9% versus 14.2%).
¿TVF: The rate at 5 years was comparable for the TAXUS® ATLAS Group versus the Control Group (30.5% versus 28%.
*The study was not powered for these endpoints at 5 years
|
| Study Strengths & Weaknesses |
Sponsor had a high follow-up rate. The stent thrombosis rate was higher in the treatment group. The study was not adequately powered to detect differences in stent thrombosis rates.
|
| Recommendations for Labeling Changes |
Yes, to update with the five year final study results.
|
