Prospective Registry to Asses the Long-term Safety and Performance of the Combo Stent

Study Overview
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Brief Summary
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Patients with stenosis in one or more coronary artery are often treated with a percutaneous coronary intervention (PCI). As part of the PCI treatment a stent is often placed to keep the vessel open over time. The Combo-Stent is a novel stent for use during percutaneous angioplasty. In short, the Combo stent combines a drug eluting technique and an endothelial cell attracting layer. The drug coating is designed to prevent re-narrowing of the stent. The endothelial cell attracting layer is designed to ensure rapid coverage of the stent struts with vascular wall cells. The REMEDEE REGISTRY evaluates the long-term safety and performance of the Combo stent in routine clinical practice. In total 1000 patients will be registered and followed for five years.

Detailed Description
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Registry Investigated Device: The OrbusNeich Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) consists of a 316L stainless steel alloy abluminally coated with a biocompatible, biodegradable polymer containing sirolimus. Covalently attached to this matrix is a layer of murine, monoclonal, anti-human CD34 antibody. The antibody specifically targets CD34+ cells in circulation. Endothelial progenitor cells (EPCs) are CD34+. The stent is supplied premounted on a 0.014 guide wire compatible low profile rapid exchange balloon catheter delivery system. The Combo Stent is Conformitée Européenne (CE) marked. Registry Objectives: The REMEDEE REGISTRY evaluates the long term safety and performance of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered Sirolimus Eluting Stent) in routine clinical practice. The primary objective of the registry is to evaluate the one year incidence of target lesion failure in consecutive patients undergoing percutaneous coronary intervention with (attempted) Combo stent placement. Registry Design: The REMEDEE REGISTRY is an international, prospective, multicenter, cohort post market registry with five years follow-up to evaluate outcomes in patients undergoing percutaneous coronary intervention with (attempted) Combo stent placement. The registry population consists of consecutive patients in whom a treatment with a Combo stent in the setting of routine clinical care is attempted. This registry involves the collection of baseline demographic, clinical, and angiographic data, as well as follow-up data in consecutive patients in whom the Combo stent is used to treat (a) coronary lesion(s) in the setting of routine clinical care. Patients are registered in up to 10 European high volume PCI centers. A follow-up is scheduled at 30 days, 180 days,1 year, 2 years, 3 years, 4 years and 5 years post procedure. Follow-up is obtained at a planned regular visit to the out-patient clinic, or by telephone contact with the patient. Quality control: All data will be entered on-site in an electronic case report (eCRF) form according to Good Clinical Practice guidelines. All sites will monitored regularly during the time of the registry. The monitor plan involves a hundred percent procedural information and event monitoring. During data monitoring, all source data will be assessed for accuracy, completeness, and representativeness of registry data by comparing the data to external data sources. Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry are implemented in the (eCRF). A data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used, and normal ranges if relevant is part of the database and eCRF design. Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management are in place. A detailed statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol is available. Missing data is accounted for in the design of the eCRF template, and will be handled according to the statistical plan.

Official Title
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Multicenter, Prospective, Clinical Outcomes After Deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio- Engineered Sirolimus Eluting Stent) Post Market Registry

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Combo stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive patients eligible for Combo stent placement by percutaneous coronary intervention are included in the REMEDEE REGISTRY Exclusion Criteria: 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 <1 year 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Combo stent<br>Consecutive patients in whom a treatment with a Combo stent in the setting of routine clinical care is attempted are entered into the registry. | Device: Combo stent<br>* Percutaneous coronary intervention of patients with an indication for stent treatment with the COMBO stent, a stent with an endothelial progenitor cell attracting coating and abluminal sirolimus matrix. All consecutive patients treated with, or attempted treatment with, a COMBO stent are followed by telephone contact for 5 years.<br>* Other names: SirolimusECS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjudicated Target Lesion Failure | 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 nontarget vessel, or target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting). | 1 year post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjudicated Target Lesion Failure | 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 nontarget vessel, or target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting). | 30 days post-procedure | 
| Adjudicated Target Lesion Failure | 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 nontarget vessel, or target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting). | 180 days post procedure | 
| Individual components of target lesion failure (TLF) | Individual components of target lesion failure (TLF): Cardiac death Non-fatal MI not clearly attributable to a non-target vessel Target lesion revascularization (TLR) | 1 year post-procedure | 
| Individual components of target lesion failure (TLF) | Individual components of TLF: Cardiac death Non-fatal MI not clearly attributable to a non-target vessel Target lesion revascularization (TLR) | 30 days post-procedure | 
| Individual components of target lesion failure (TLF) | Individual components of TLF: Cardiac death Non-fatal MI not clearly attributable to a non-target vessel Target lesion revascularization (TLR) | 180 days post-procedure | 
| Individual components of target lesion failure (TLF) | Individual components of TLF: Cardiac death Non-fatal MI not clearly attributable to a non-target vessel Target lesion revascularization (TLR) | 1 year post-procedure | 
| Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) | Adjudicated patient-oriented composite MACE as a composite of: All death Any myocardial infarction Any revascularization | 1 year post-procedure | 
| Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) | Adjudicated patient-oriented composite MACE as a composite of: All death Any myocardial infarction Any revascularization | 30 days post-procedure | 
| Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) | Adjudicated patient-oriented composite MACE as a composite of: All death Any myocardial infarction Any revascularization | 180 days post-procedure | 
| Each of the individual components of Major Adverse Cardiac Events(MACE) | Each of the individual components of MACE: All death Any myocardial infarction Any revascularization | 1 year post-procedure | 
| Adjudicated stent thrombosis (definite/probable/possible) | Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions | 1 year post-procedure | 
| Adjudicated stent thrombosis (definite/probable/possible) | Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions | 30 days post-procedure | 
| Adjudicated stent thrombosis (definite/probable/possible) | Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions | 180 days post-procedure | 
| 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 | Procedural | 
| Procedure success | Successful stent placement and no periprocedural complications. | Procedural | 
| Adjudicated Target Lesion Failure | 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 nontarget vessel, or target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting). | 2 years post-procedure | 
| Adjudicated Target Lesion Failure | 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 nontarget vessel, or target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting). | 3 years post-procedure | 
| Adjudicated Target Lesion Failure | 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 nontarget vessel, or target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting). | 4 years post-procedure | 
| Adjudicated Target Lesion Failure | 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 nontarget vessel, or target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting). | 5 years post-procedure | 
| Individual components of target lesion failure (TLF) | Individual components of target lesion failure (TLF): Cardiac death Non-fatal MI not clearly attributable to a non-target vessel Target lesion revascularization (TLR) | 2 years post-procedure | 
| Individual components of target lesion failure (TLF) | Individual components of target lesion failure (TLF): Cardiac death Non-fatal MI not clearly attributable to a non-target vessel Target lesion revascularization (TLR) | 3 years post-procedure | 
| Individual components of target lesion failure (TLF) | Individual components of target lesion failure (TLF): Cardiac death Non-fatal MI not clearly attributable to a non-target vessel Target lesion revascularization (TLR) | 4 years post-procedure | 
| Individual components of target lesion failure (TLF) | Individual components of target lesion failure (TLF): Cardiac death Non-fatal MI not clearly attributable to a non-target vessel Target lesion revascularization (TLR) | 5 years post-procedure | 
| Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) | Adjudicated patient-oriented composite MACE as a composite of: All death Any myocardial infarction Any revascularization | 2 years post-procedure | 
| Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) | Adjudicated patient-oriented composite MACE as a composite of: All death Any myocardial infarction Any revascularization | 3 years post-procedure | 
| Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) | Adjudicated patient-oriented composite MACE as a composite of: All death Any myocardial infarction Any revascularization | 4 years post-procedure | 
| Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) | Adjudicated patient-oriented composite MACE as a composite of: All death Any myocardial infarction Any revascularization | 5 years post-procedure | 
| Adjudicated stent thrombosis (definite/probable/possible) | Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions | 2 years post-procedure | 
| Adjudicated stent thrombosis (definite/probable/possible) | Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions | 3 years post-procedure | 
| Adjudicated stent thrombosis (definite/probable/possible) | Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions | 4 years post-procedure | 
| Adjudicated stent thrombosis (definite/probable/possible) | Adjudicated stent thrombosis (definite/probable/possible) per Academic Research Consortium definitions | 5 years post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stents, Stent, Drug eluting, Drug eluting stent, Drug eluting stents, Endothelial progenitor cell, Endothelial progenitor cell capturing, Sirolimus, Sirolimus eluting, Percutaneous Coronary Intervention, PCI, Registry, Registries, Multi center, Multi centre