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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110004 / PAS001 |
| Date Original Protocol Accepted |
04/12/2012
|
| Date Current Protocol Accepted |
04/12/2012
|
| Study Name |
Continued f/u of BLAST Placebo Cohort
|
| Device Name |
PRESILLION PLUS COCR CORONARY STENT RX SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
|
| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a non-randomized, multi-center, prospective, single arm clinical
study.
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| Study Population |
Patients with symptomatic ischemic heart disease due to a single de novo stenotic lesion contained within native coronary artery with reference vessel diameter between 2.5 mm and 4.0 mm and lesion length less than or equal to 30 mm that is amenable to percutaneous revascularization with percutaneous coronary intervention with stent deployment.
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| Sample Size |
131 patients enrolled from up to 15 sites in the USA.
Assumptions:
¿ Three-year TVF rate for bare metal stents derived from the meta- analysis is 22%. (95% CI 17.7%, 26.4%).
¿ Performance goal for bare metal stents = 33%
¿ Type I error (a) = 0.05 (one-sided)
¿ Statistical power (1 – ß) = 80%
¿ Expected rate for TVF at 3 years for Presillion plus Stent System = 22%
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| Key Study Endpoints |
Primary Endpoint
Target vessel failure (TVF), defined as cardiac death, target vessel
myocardial infarction (MI) [Q wave or non-Q wave], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 3 years post-procedure.
The secondary safety endpoints are:
All Death at 30 days, 1, 2 and 3 years
Cardiac Death at 30 days, 1, 2 and 3 years
All cause MI at 30 days, 1, 2 and 3 years
Target vessel MI at 30 days, 1, 2 and 3 years
Clinically driven TVR at 30 days, 1, 2 and 3 years
Clinically driven target lesion revascularization (TLR) at 30 days, 1, 2 and 3 years
Acute Success Rates
Device Success: Attainment of < 50% final residual stenosis of
the target lesion using only Presillion plus Stent Systems.
Lesion Success: Attainment of < 50% final residual stenosis of the target lesion using any percutaneous method.
Procedure Success: Attainment of < 50% residual stenosis of the target lesion and no in-hospital death, MI, or TLR.
Stent Thrombosis at hospital discharge, at 30 days, 1, 2 and 3 years.
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| Follow-up Visits and Length of Follow-up |
Patients will be followed-up for 3 years. Follow-up will be performed at
30 days, 1, 2, and 3 years post-procedure.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
74 subjects
|
| Actual Number of Sites Enrolled |
12 sites
|
| Patient Follow-up Rate |
93.2% (69/74)
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| Final Safety Findings |
The rates [95% Confidence Interval] through 5 years were:
Major Adverse Cardiac Events: 41.7% (30/72) [30.2%, 53.9%]
Clinically driven target lesion(s) revascularization: 20.8% (15/72) [12.2%, 32.0%] All-cause mortality: 2.8% (2/72) [0.3%, 9.7%]
Myocardial Infarction (MI) (ST-segment elevation MI and non-ST segment elevation MI): 27.8% (20/72) [17.9%, 39.6%]
Stent Thrombosis: 2.8% (2/72) [0.3%, 9.7%] Acute: 0.0% (0/72) [0.0%, 5.0%]
Sub-acute: 1.4% (1/72) [0.0%, 7.5%]
Late: 1.4% (1/72) [0.0%, 7.5%]
Very Late: 0.0% (0/72) [0.0%, 5.0%]
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| Final Effect Findings |
The rate of cardiac death and MI through 5 years was 29.2% (21/72) [19.0%, 41.1%].
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| Study Strengths & Weaknesses |
This study provides longer term (5 years) safety and effectiveness results of Presillion CoCr Coronary Stent RX System. The study had a low rate of attrition, thus minimizing selection bias. This study follows up the premarket cohort to provide earlier, descriptive information on long-term performance, as such the study had a small sample size and its results are descriptive. The generalizability of the results from this outside the United States population is limited to Israeli patients. This limitation is being addressed through the conduct of the second condition of approval study, ¿Enrollment of New US Cohort¿. The combined data will provide early information on long-term device performance and generalizable, statistically powered findings.
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| Recommendations for Labeling Changes |
A labeling change is recommended to add a summary of the post-approval study results including study strengths and limitations. The updated label will reflect the long-term (5-years) postmarket performance of the device.
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