|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P160014 / PAS001 |
Study Name |
Cont f/u of PzF SHIELD IDE Cohort
|
Device Name |
COBRA PzF NanoCoated Coronary Stent System
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
Objective Performance Criterion
|
Analysis Type |
Analytical
|
Study Population |
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
Continued follow-up of premarket cohort
|
Study Population |
Single arm study with COBRA device
|
Sample Size |
296 (already enrolled)
|
Key Study Endpoints |
The primary combined safety and effectiveness endpoint is the incidence of target vessel failure (TVF) within 270 days of treatment with the COBRA PzF™ Coronary Stent System. In-stent late lumen loss at 9 months post-implant is a powered secondary endpoint. These endpoints have already been met. Additional secondary endpoints include clinically driven target lesion revascularization and definite or probable stent thrombosis.
|
Follow-up Visits and Length of Follow-up |
5 years Annually
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
296
|
Actual Number of Sites Enrolled |
35
|
Patient Follow-up Rate |
30, 180, 270, 360, 720, 1080,1 440, 1800 days
|
Final Safety Findings |
At 5 year follow-up, there were a total of 11 deaths adjudicated as cardiac and 23 as non-cardiac, for an all-cause mortality rate of 12.0%. There were a total of 29 Mis by ARC definition within 5 years for an MI rate of 11.3%. The clinically driven TLR rate at 1800 days was 13.5%. There were 9 cases of possible stent thrombosis events through 5 years but no definite or porpable stent thrombosis was reported.
|
Final Effect Findings |
The trial primary endpoint was met: The rate of TVF at 270 days was 11.4% (33/290 patients). The upper limit of the one -sided exact 95% CI was 14.81%, which met the performance goal of 19.62%. The trial powered secondary endpoint was met: The mean in-stent late loss per patient at 270 days was 0.84 (± 0.48)mm with an upper bound of the one-sided 95% CI of 0.93 mm. This was below the performance goal of 1.1 mm.
|
Study Strengths & Weaknesses |
Single arm trial with a limited sample size for confirmatory analysis
|
Recommendations for Labeling Changes |
The sponsor should update their labeling to include the final data from the study.
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