|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P170008 / PAS001 |
| Date Original Protocol Accepted |
11/28/2017
|
| Date Current Protocol Accepted |
|
| Study Name |
Cont f/u of BIONICS Clinical Study
|
| Device Name |
EluNIR™ Ridaforolimus Eluting Coronary Stent System
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up of premarket cohort
|
| Study Population |
Prospective, multicenter, single-blind, two-arm 1:1 randomization (EluNIR versus Resolute)
|
| Sample Size |
1919 subjects (already enrolled)
|
| Key Study Endpoints |
The primary safety and effectiveness endpoint is TLF at 12 months post-index procedure. The secondary angiographic endpoint is in-stent late lumen loss at 13-months post-index procedure. Additional clinical secondary endpoints include acute success (device, lesion, and procedure), cardiac death, target vessel MI, target lesion revascularization, MACE, target lesion failure, target vessel failure and stent thrombosis.
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1919 Patients
|
| Actual Number of Sites Enrolled |
76 Clinical sites in the US, Canada, EU and Israel
|
| Patient Follow-up Rate |
Minimum of 95% follow-up rate
|
| Final Safety Findings |
12 months
The 12-month primary effectiveness was met.
Adverse event: ([EluNIR] 86.1% vs. [Resolute] 85%)
Serious Adverse event: ([EluNIR] 55% vs. [Resolute] 54.2%)
|
| Final Effect Findings |
The main safety and effectives endpoint rates through 5 years in the BIONICS study are:
Target lesion revascularization (TLR): ([EluNIR] 7.8% vs. [Resolute] 6.8 %), Target lesion failure (TLF): ([EluNIR] 12.5% vs. [Resolute] 11.4%), Target vessel revascularization (TVR): ([EluNIR] 12.7% vs [Resolute] 9.3%, Target vessel failure (TVF): ([EluNIR] 18.8% vs. [Resolute] 18.0%), myocardial infraction : ([EluNIR] 11% vs. [Resolute] 10.3%), Cardiac death : ([EluNIR] 3.5% vs. [Resolute] 2.4%), Definite + probable Stent thrombosis : ([EluNIR] 1.0% vs. [Resolute] 0.9%, MACE: ([EluNIR] 17.4% vs. [Resolute] 15.8%, p = 0.46)
|
| Study Strengths & Weaknesses |
This was a randomized controlled trial that met its primary endpoint. However, the trial was conducted primarily in a non-US population
|
| 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.
|
