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.
Study Type
OBSERVATIONAL
Enrollment
2,000
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.
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk, South Korea
Dankook University Hospital
Cheonan, Chungcheongnam, South Korea
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
Time frame: 12 months
Patient-oriented composite end point
Composite of any death, any myocardial infarction, and any revascularization
Time frame: 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
Time frame: 12 months
Non-cardiac death
Any death not covered by the cardiac death
Time frame: 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
Time frame: 12 months
Any myocardial infarction not clearly attributable to a nontarget vessel
Any myocardial infarction not clearly attributable to a nontarget vessel
Time frame: 12 months
Any revascularization
Any repeat revascularization including all target and nontarget vessel
Time frame: 12 months
Clinically indicated target-lesion revascularization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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, 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
...and 7 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months