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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P060008 S008/ PAS001 |
| Date Original Protocol Accepted |
07/23/2009
|
| Date Current Protocol Accepted |
07/23/2009
|
| Study Name |
TAXUS ATLAS Small Vessel
|
| Device Name |
TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| 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.
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| Study Population |
The TAXUS Liberté Atom (2.25 mm) 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 > 2.25 mm to < 4.00 mm in diameter in lesions < 28 mm in length.
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| Sample Size |
168 subjects, 100 sites
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| 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.
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| 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 |
| Actual Number of Patients Enrolled |
261 TAXUS ATLAS patients, 75 DES control, 155 BMS control
|
| Actual Number of Sites Enrolled |
23
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| Patient Follow-up Rate |
91.3% TAXUS ATLAS, 90.4% DES Control, 85.5% BMS Control. These percentages include patients who died in both the numerator and denominator.
|
| Final Safety Findings |
MACE (cardiac death, MI, and TVR): The rate at 5 years was 26.3 in the TAXUS ATLAS Group and 36.9% in the DES Control group and 44.4% in the BMS Control group.
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| Final Effect Findings |
TVR, TLR and TVF rates at 5 years were 20.1%, 13.4% and 25.6%, respectively, for the TAXUS ATLAS Group. The rates for the DES Control Group were 30.8% (TVR), 23.1% (TLR) and 35.4% (TVF). The rates for the BMS Control Group were: 38.3% (TVR), 32.3% (TLR), and 42.9% (TVF).
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| Study Strengths & Weaknesses |
The sponsor present a well designed study with a control group with good follow-up at 5 years.
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| Recommendations for Labeling Changes |
Updated to include the long-term post-approval study data and findings.
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