A U.S Post Approval Study Evaluating the SYNERGY XLV (MEGATRON) Stent System

Study Overview
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Brief Summary
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This is a post-market, standard of care, real-world observational study to assess the clinical outcomes of the SYNERGY XLV (MEGATRON) Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 28 mm in length (by visual estimate) in native coronary arteries ≥3.50 mm to ≤5.00 mm in diameter (by visual estimate). This Post Approval study is a cohort associated with the Evolve 4.5/5.0 (SYNERGY LV) Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT03875651.

Official Title
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A U.S. Post-Approval Study of the SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System Evaluating the SYNERGY XLV (MEGATRON) Stent System

Conditions
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Atherosclerosis, Heart Diseases, Coronary, Coronary Artery Disease, Cardiovascular Diseases

Intervention / Treatment
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* Device: SYNERGY XLV (Megatron) Coronary Stent System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient requires treatment with a SYNERGY XLV (Megatron) stent Exclusion Criteria: Planned treatment with a non-SYNERGY stent

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 |
| --- | --- |
| SYNERGY XLV (Megatron) Coronary Stent System<br>The SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System), manufactured by BSC, is a device/drug combination product comprised of two regulated components: a device (Coronary Stent System) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating). | Device: SYNERGY XLV (Megatron) Coronary Stent System<br>* The SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those at high risk for bleeding, with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries >3.50 mm to <5.00 mm in diameter in lesions <28 mm in length.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF) rate | 12-month Target Lesion Failure (TLF) rate, defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical endpoints | TLR rate, TLF rate (primary endpoint at 12 months), Target vessel revascularization (TVR) rate, Target vessel failure (TVF) rate, MI (Q-wave and non-Q-wave) rate, Cardiac death rate, Non-cardiac death rate, All death rate, Cardiac death or MI rate, All death or MI rate, All death/MI/TVR rate, Stent thrombosis rates (ARC) | At Hospital Discharge (typically 1-2 days post index procedure), and at 6 months, 12 months, 2 years | 
| Periprocedural endpoints | Technical success rate, Clinical procedural success rate | At Hospital Discharge (typically 1-2 days post index procedure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-Eluting Stents