XIENCE Skypoint Large Vessel Post Approval Study

Study Overview
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Brief Summary
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SPIRIT XLV PAS is a prospective, single arm, multi-center, US and OUS post-approval observational study to evaluate the continued safety and effectiveness of the XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS) Large Vessel (LV) sizes (diameter 4.5 mm and 5.0 mm) during commercial use in a real-world setting.

Official Title
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XIENCE Skypoint Large Vessel Post Approval Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Inclusion Criteria Subject must be at least 18 years of age. Subject or a legally authorized representative must provide written informed consent per site requirements. Subject must have evidence of myocardial ischemia (STEMI, NSTEMI, Unstable Angina or Stable Angina) or who have silent ischemia with evidence of ischemia, appropriate for PCI treatment with DES. Subject with stable angina or silent ischemia must have objective sign of ischemia as suggested by one of the following: Abnormal stress or imaging stress test Abnormal computed tomography-fractional flow reserve (CT-FFR) Stenosis by visual estimation ≥ 70% Abnormal pressure-derived indexes (FFR, instantaneous wave-free ratio [iFR], or relative flow reserve [RFR]) Subject must agree not to participate in any other clinical study for a period of one year following the index procedure. Angiographic Inclusion Criteria Patients who have lesion(s) in a vessel with reference vessel diameter > 4.25 mm and ≤ 5.25 mm as the target lesion Patients who receive at least one Skypoint LV stent Lesions with RVD ≤ 4.25 mm should be treated as the non-target lesions during the index procedure with commercially available XIENCE family of stents Up to three lesions (target and non-target) in two coronary vessels can be treated at the index procedure. Exclusion Criteria: General Exclusion Criteria Patients who have contraindications of the Skypoint LV per the IFU Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months. Angiographic Exclusion Criteria: Patients who require three vessel treatment. If left main coronary artery (LMCA) is the intended target vessel, patients who have unprotected left main disease with the SYNTAX Score ≥ 23 Unprotected LM disease with a SYNTAX score ≤ 22 (site-assessment) can be treated as the target lesion but not to exceed 40% of the study population A heart team consensus approach per site's standard of care (SOC) to enhance patient protection and optimal clinical practice for the left main treatment is required.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System<br>Subjects who were implanted with XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System will be included. | Device: XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS)<br>* XIENCE Skypoint Large Vessel EECSS is composed of a L-605 CoCr stent and coated with poly (n-butyl methacrylate) (PBMA) primer and a drug coating formulation of polymer of vinylidene fluoride and hexafluoropropylene (PVDF-HFP)/everolimus pre-mounted on a balloon catheter delivery system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Target Lesion Failure (TLF) at 1 year | TLF is defined as the composite of cardiac death, myocardial infarction related to the target vessel (TV-MI), or ischemic driven target lesion revascularization (ID-TLR). | At 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABT -CIP 10445, Coronary artery disease, XIENCE, Large Vessel, Skypoint