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| General |
| Study Status |
Progress Adequate |
| Application Number |
P110004 S001/ PAS001 |
| Date Current Protocol Accepted |
11/01/2017
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| Study Name |
NIRTRAKS PAS
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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 Design Description |
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 Description |
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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| Data Collection |
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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