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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110004 S001/ PAS001 |
| Date Original Protocol Accepted |
05/14/2015
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| Date Current Protocol Accepted |
11/01/2017
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| Study Name |
NIRTRAKS PAS
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| Device Name |
NIRXCELL COCR CORONARY STENT ON RX SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US). All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted.
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| Study Population |
Subjects with symptomatic ischemic heart disease due to a single de novoI stenotic lesion contained within a native coronary artery with a 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 stent deployment.
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| Sample Size |
Per agreement with the FDA (P110004/S021), only 65 of the originally 131 planned subjects will be enrolled. Assuming loss of approximately 7.0% per year, there is anticipated to be approximately 52 evaluable subjects after 3 years.
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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.
Secondary endpoints
-TVF at 9 months
-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 |
February 14, 2017, 65 of the planned 131 subjects were enrolled in the study.
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| Actual Number of Sites Enrolled |
8 Total clinical sites. 5 sites enrolled subjects. 3 of the initially 8 enrolled sites were closed due to no enrollment
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| Patient Follow-up Rate |
Of the 65 subjects enrolled, all (100%) completed the 30-day visit.
Between 30 days and 9 months, one subject died for a total of 64 subjects eligible for the 9-month visit; 62 (96.9%) completed the visit.
Between 9 months and 1 year, one subject died, and one was lost to follow-up for a total of 62 subjects eligible for the 1-year visit; 61 (98.4%) completed the visit.
Between 1 and 2 years, 5 subjects died, one subject withdrew consent to participate, and one subject was lost to fol
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| Final Safety Findings |
There have been no device malfunctions, failures or misuse issues reported since the writing of the previous Interim PAS Status Report in December 2018. The number of devices that had malfunctions, failures or misuse, and the number of subjects who experienced those incidents since the start of the study are summarized in Table 4.
Overall, 89.23% of subjects experience at least one AE. The most frequent AEs were cardiac disorders experienced by 37 of 65 (56.92%) enrolled subjects. Compared to the 2019 report that had 230 AEs with 65 cardiac disorders, the 2020 report is reporting 239 AEs with 69 cardiac disorders. See Table 5 in the submission for details.
Overall, 40 of 65 (61.54%) enrolled subjects experience at least one SAE. The most frequent SAEs were cardiac disorders experienced by 29 of 65 (44.62%) enrolled subjects. Compared to the 101 SAEs and 41 cardiac disorders, the 2020 report had 108 SAEs with 43 cardiac disorders.
There have been no unanticipated serious adverse device effects (SADEs) reported as of the data export data (July 7th, 2019).
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| Final Effect Findings |
The data for the primary endpoint of TVF at 3 consisted of a total of 61 subjects that experienced an event or had sufficient follow-up to be included in the analysis. Of these, 15/61 (24.6%) experienced a TVF event with a breakdown of 11.5% (7/61) suffering cardiac death, 8.2 % (5/61) experiencing Target Vessel MI, and 13.1% (8/61) experiencing clinically-driven target vessel restenosis.
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| Study Strengths & Weaknesses |
This study is a new enrollment prospective trial evaluated the long term performance of the NIRxcell device. The study is limited by the low overall enrollment.
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| Recommendations for Labeling Changes |
No changes recommended as the device has been official withdrawn from the market.
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