Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Genoss Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This registry is a clinical post-market evaluation of the Genoss DES in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genoss DES | Subject implanted Genoss DES for coronary artery disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genoss DES | Device | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Junghan Yoon, MD, PhD | Wonju Severance Christian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk National University Hospital | Cheongju-si | Chungcheongbuk | South Korea | |||
| Dankook University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 12 months |
| Cheonan |
| Chungcheongnam |
| South Korea |
| Chuncheon Sacred Heart Hospital | Chuncheon | Gangwon-do | South Korea |
| Kangwon National University Hospital | Chuncheon | Gangwon-do | South Korea |
| Gangneung Asan Hospital | Gangneung | Gangwon-do | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | Gangwon-do | 220060 | South Korea |
| Inje University Ilsan Paik Hospital | Goyang-si | Gyeonggi-do | South Korea |
| Myongji Hospital, Hanyang University College of Medicine | Goyang-si | Gyeonggi-do | South Korea |
| National Health Insurance Service Ilsan Hospital | Goyang-si | Gyeonggi-do | South Korea |
| CHA Bundang Medical Center | Seongnam-si | Gyeonggi-do | South Korea |
| Kosin University Gospel Hospital | Busan | South Korea |
| Gachon University Gil Medical Center | Incheon | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Kangnam Sacred Heart Hospital | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Severance Cardiovascular Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided