MASCOT - Post Marketing Registry

Study Overview
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Brief Summary
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To collect post marketing surveillance data on patients receiving at least one Combo Bio-Engineered Sirolimus Eluting Stent when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Combo Stent in routine clinical practice.

Detailed Description
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The multicenter, multinational, prospective registry population consists of patients who undergo percutaneous coronary intervention (PCI) with (attempted) placement of at least one Combo Stent (according to the Instructions for use) as part of routine clinical care. Approximately 2,500 patients from 50 centers in Europe and Asia will be entered into the registry. Patients entered into the registry are followed for one year. The registry is considered finished when all patients have completed the 12 month follow-up. A follow-up is scheduled at 30 days, 6 months and 12 months post procedure. Follow-up is obtained at a planned regular visit to the outpatient clinic, or by telephone contact with the patient.

Official Title
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Multinational Abluminal Sirolimus Coated BiO-Engineered StenT - The MASCOT Post Marketing Registry

Conditions
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Atherosclerosis, Coronary Artery Disease

Intervention / Treatment
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* Device: OrbusNeich COMBO stent


Participation Criteria
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Eligibility Criteria
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In general, consecutive patients are included in the registry. Patients are only excluded from registration if ANY of the following conditions apply: Undergoing PCI for treatment of stent thrombosis High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned A life expectancy of <12 months Explicit refusal of participation in the registry

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

| Intervention/Treatment |
| --- |
|Device: OrbusNeich COMBO stent|The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjudicated device-oriented composite target lesion failure (TLF) | Adjudicated device-oriented composite target lesion failure (TLF) defined as a composite of cardiac death, non-fatal myocardial infarction (MI) not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting (CABG)) at 12 months post procedure. | 12 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjudicated TLF |  | at index procedure, 30 days, 6 months and 12 months post procedure | 
| Each of the components of TLF (Cardiac death, Non-fatal MI not clearly attributable to a non-target vessel, Target lesion revascularization (TLR)) |  | at index procedure, 30 days, 6 months, 12 months | 
| Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) as a composite of all Death, any MI and ischemia-driven revascularization (TLR/TVR/non-TVR) |  | at index procedure, 30 days, 6 months and 12 months | 
| Each of the components of MACE (All death, Any myocardial infarction, Ischemia-driven revascularization) |  | at index procedure, 30 days, 6 months and 12 months | 
| Adjudicated stent thrombosis per the Academic Research Consortium (ARC) definition |  | at index procedure, 30 days, 6 months and 12 months post-procedure | 
| Adjudicated bleeding per the Bleeding Academic Research Consortium (BARC) definition |  | at index procedure, 30 days, 6 months and 12 months post-procedure | 
| Adjudicated stroke |  | at index procedure, 30 days, 6 months and 12 months | 
| Device success: Percentage of patients with a successful delivery and deployment of the Combo Stent to the target lesion and a final diameter stenosis after stenting ≤20% by visual assessment in the presence of grade 3 TIMI flow, by visual estimation |  | Index Procedure | 
| Procedure success: Successful stent placement and no peri-procedural complications. |  | Index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracoronary stent, drug eluting stent, sirolimus, endothelial progenitor cells