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General |
Study Status |
Other |
Application Number / Requirement Number |
P110004 / PAS002 |
Date Original Protocol Accepted |
04/12/2012
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Date Current Protocol Accepted |
04/12/2012
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Study Name |
Enrollment of New US Cohort
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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
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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 |
The study is a prospective multi-center, non-randomized, single arm clinical study designed to collect information about the safety and effectiveness of the NIRxcell CoCr Coronary Stent RX System in the treatment of de novo stenotic lesions in native coronary arteries in a newly enrolled US population.
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Study Population |
A sample size of 131 evaluable patients is needed to demonstrate that the NIRxcell CoCr Coronary Stent RX System TVF rate is less than 33% after three years (80% power and one-sided a=0.05). This sample size accounts for an expected loss to follow-up of approximately 7.5% per year. Patients will be enrolled from up to 15 sites in the USA.
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Sample Size |
see Study population
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Key Study Endpoints |
The primary effectiveness endpoint for this study is 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 Acute Success Rates Device Success: Attainment of < 50% final residual stenosis of the target lesion using only NIRxcell? 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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