Genoss DES Prospective Multicenter Registry

Study Overview
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Brief Summary
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This registry is a clinical post-market evaluation of the Genoss DES in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

Detailed Description
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Percutaneous coronary intervention (PCI) is the main stream of treatment of coronary artery disease. Drug-eluting stents (DES) have dramatically reduced the rates of restenosis and target lesion revascularization (TLR) compared with bare-metal stents (BMS). Newer-generation DES with a durable polymer such as Xience (Abbott, US) and Resolute (Medtronic, US) were widely used. However, the concern about late stent thrombosis due to hypersensitivity reaction from the polymer is still existed. Recently, DES with a biodegradable polymer such as Biomatrix (Biosensors, Switzerland), Nobori (Terumo, Japan), Orsiro (Biotronik, Switzerland), and Synergy (Boston Scientific, US) was rapidly adopted and it is expected to reduce the late stent thrombosis. Recently, new biodegradable DES with thin struts was developed in South Korea. The Genoss DES (Genoss, Korea) has an L-605 cobalt chromium (CoCr) platform with a strut thickness of about 70 µm and the stent is coated a combination of Sirolimus drug with concentration of 1.15µg/mm2 and an abluminal biodegradable PLA and PLGA polymers. This study is conducted to evaluate efficacy and safety of Genoss DES in the treatment of patients with coronary artery disease.

Official Title
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Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of GENOSS Sirolimus-eluting Stent in Patients With Coronary Artery Disease (GENOSS Registry)

Conditions
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Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction

Intervention / Treatment
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* Device: Genoss DES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 19 years Subject implanted Genoss DES within 1 month Subject has signed informed consent for data release Subject is geographically stable and willing to participate at all follow-up assessments Exclusion Criteria: Subject did not sign informed consent for data release Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, Sirolimus or contrast media Pregnancy Subject with life expectancy less than 12 months Subject with cardiogenic shock Planned surgery within 12 months of PCI unless dual antiplatelet therapy will be maintained Currently participating in another study and primary endpoint is not reached yet.

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| Genoss DES<br>Subject implanted Genoss DES for coronary artery disease | Device: Genoss DES<br>* The Genoss DES (Genoss, Korea) L-605 cobalt chromium (CoCr) platform with a strut thickness of 70 µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-oriented composite end point (TLF) | Composite of cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target-lesion revascularization | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-oriented composite end point | Composite of any death, any myocardial infarction, and any revascularization | 12 months | 
| Cardiac death | Any death due to proximate cardiac cause, unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment | 12 months | 
| Non-cardiac death | Any death not covered by the cardiac death | 12 months | 
| Any myocardial infarction | New symptom Symptoms suggestive of ischemia + increased cardiac enzyme (Troponin >URL or CKMB >URL) or New ST elevation or LBBB | 12 months | 
| Any myocardial infarction not clearly attributable to a nontarget vessel | Any myocardial infarction not clearly attributable to a nontarget vessel | 12 months | 
| Any revascularization | Any repeat revascularization including all target and nontarget vessel | 12 months | 
| Clinically indicated target-lesion revascularization | Any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent. | 12 months | 
| Clinically indicated target-vessel revascularization | any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. | 12 months | 
| ARC defined stent thrombosis | Definite stent thrombosis Angiographic confirmation of stent thrombosis Pathological confirmation of stent thrombosis Probable stent thrombosis - Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Possible stent thrombosis - Clinical definition of possible stent thrombosis is considered to have occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Observational registry, All-comers open label registry, Genoss DES, Multicenter, Stenting, Coronary Artery Disease, Coronary revascularization, Percutaneous Coronary Intervention