Safety and Clinical Performance of the Yukon Choice PC, Yukon Chrome PC & Yukon Choice Flex Stents in Routine Practice

Study Overview
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Brief Summary
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The goal of this observational study is to collect safety and performance information in the setting of a large-scale clinical registry. Patients meeting the selection criteria will be included, in chronological order of their implantation. This registry does not require any additional procedures, follow-up interventions, or ionizing radiation for patients. The inclusion period is planned to last 2 years, starting in Q1 2023. The study will be complete when data on all patient's follow-up for one year have been collected.

Detailed Description
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Prospective, observational, noninterventional, multicenter, international clinical registry Allocation: consecutively treated patients, non-randomized Masking: None (open label) Observational model: Longitudinal Inclusion period: 2 years Follow-up period: at 1 year Study duration: 3 years Patients meeting the selection criteria will be included, in chronological order of their implantation. This registry does not require any additional procedures, follow-up interventions, or ionizing radiation for patients. The inclusion period is planned to last 2 years, starting in Q1 2023. The study will be complete when data on all patient's follow-up for one year have been collected. List of visits: V0: During hospitalization: consultation baseline, data of the intervention and data at discharge V1: consultation at 30 days Follow-Up V2: consultation at 12 months Follow-Up

Official Title
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Safety and Clinical Performance of the Yukon Choice PC, Yukon Chrome PC & Yukon Choice Flex Sirolimus Eluting Bioabsorbable Polymer Stents Systems in Routine Clinical Practice: e-Yukon Global Registry.

Conditions
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Ischemic Heart Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient who was implanted only with a Yukon Choice PC, a Yukon Chrome PC or/and a Yukon Choice Flex stent within previous 2 days. Patient ≥ 18 years old. Male or non-pregnant female patient (Note: females of childbearing potential must have a negative pregnancy test prior to enrollment in the study). Exclusion Criteria: Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints. Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements or impact the scientific integrity of the trial. Concurrent medical condition with a life expectancy of less than 12 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure | Defined as the composite of cardiac death, target-vessel myocardial infarction and clinically indicated target lesion revascularization | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success | Defined as successful delivery and deployment of the assigned device at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-stent residual stenosis of <30% (by visual estimation). | 12 months | 
| Procedure Success | Device success without the occurrence of an ischemia-driven major adverse cardiac event during the hospital stay to a maximum of first seven days post index procedure. | 12 months | 
| All cause death | Defined as the rate of death from any cause | 12 months | 
| Cardiac death | Defined as death resulting from cardiovascular causes | 12 months | 
| Myocardial infarction | Defined as the rate of myocardial infarction | 12 months | 
| Target-vessel myocardial infarction | Defined as a myocardial infarction occurring on the stented target vessel | 12 months | 
| Clinically driven target lesion revascularization | Defined as a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication involving the target lesion | 12 months | 
| Any revascularization | defined as clinically driven target lesion revascularization or angiographically driven target lesion revascularization, performed due to angiographic detection of significant restenosis in a patient who is clinically asymptomatic. | 12 months | 
| Stent Thrombosis | Defined as a thrombotic occlusion of a coronary stent (definite or probable, as per Academic Research Consortium definitions) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stent, ischemic heart disease, registry, international, routine practice