NCT03045913

Genoss DES Prospective Multicenter Registry

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (actual)
• Sponsor: Young Jin Youn, MD, PhD · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Coronary Artery Disease
• Myocardial Ischemia
• Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Genoss DES	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.

Timeline

• Start date: 2016-11-18
• Primary completion: 2021-11-29
• Completion: 2022-12-31
• First posted: 2017-02-08
• Last updated: 2023-01-30

Locations

17 sites across 1 country: South Korea