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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110010 S001/ PAS002 |
| Date Original Protocol Accepted |
06/01/2012
|
| Date Current Protocol Accepted |
08/23/2012
|
| Study Name |
Continued F/U of Premarket Cohort
|
| Device Name |
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up of premarket study, which is a concurrent, non-randomized, single-arm long lesion (LL) subtrial.
|
| Study Population |
Patients who met the inclusion/exclusion criteria for the PLATINUM Long Lesion (LL) sub-study, evaluating the PROMUS Element¿ Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of coronary artery disease.
|
| Sample Size |
Cohort of 102 patients at 35 sites in the U.S., Europe, IC region and Japan.
|
| Key Study Endpoints |
Target lesion revascularization (TLR) rate, target lesion failure (TLF) rate, target vessel revascularization (TVR) rate, target vessel failure (TVF) rate, myocardial infarction [ MI (Q-wave and non¿Q-wave)] rate, cardiac death rate, non-cardiac death rate, all death rate, cardiac death or MI rate, all death or MI rate, all death/MI/TVR rate, and stent thrombosis rate (definite or probable by ARC definitions)
|
| Follow-up Visits and Length of Follow-up |
5 years
18-Month, and 2, 3, 4, 5-Year Follow-Up
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
102
|
| Actual Number of Sites Enrolled |
23
|
| Patient Follow-up Rate |
86.7% at 5years
|
| Final Safety Findings |
12 months
The 12 month primary effectiveness was met. For ITT patients, the 12 month TLF rate was 3.1% (3/96)
with upper 1-sided upper confidence bound 7.88% which is significantly less than the performance goal (PG) of 19.4% (p<0.001), and for per protocol patients the 12-month TLF rate was 3.2% (3/95) with 1- sided upper confidence bound of 7.96%, significantly less than the PG, 19.4% (P<0.001).
|
| Final Effect Findings |
The main safety and effectiveness endpoint rates through 5 years in the Platinum LL sub-study are: Target lesion revascularization (TLR) 7.5%, target lesion failure (TLF) 13.6%, target vessel revascularization (TVR) 11.6%, target vessel failure (TVF) 17.7%, myocardial infarction (Q and non-Q wave) 1.3%, cardiac death 8.6%, Non cardiac death 2.2%, all death 10.6%, all death or MI 11.7%, All death, MI, TVR 20.7% and Academic Research Consortium (ARC)-defined Stent Thrombosis 1%.
|
| Study Strengths & Weaknesses |
The Long lesion study met the primary endpoint and provided long term data. However the sample size was small and subgroup analyses were not conducted.
|
| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the long term data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow –up visits etc.), final results and study strengths and limitations of the PAS.
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