NCT06066476

Efficacy and Safety of GENOSS® DES in Patients with Coronary Artery Disease

A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of GENOSS DES in Patients with Coronary Artery Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,022 (actual)
• Sponsor: Genoss Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy and safety of the GENOSS DES in patients with coronary artery disease in real-world pratice.

Detailed description

The Genoss DES is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt-chromium stent platform and thin strut. Although the efficacy and safety of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the objective of this prospective, multicenter study was to evaluate the clinical efficacy and safety of the Genoss DES in all-comer patients undergoing percutaneous coronary intervention. The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes after Genoss DES implantation in all-comer patients undergoing percutaneous coronary intervention from 12 sites in South Korea. The primary endpoint was a device-oriented composite endpoint (DOCE), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 12 months.

Conditions

• Coronary Artery Disease

Timeline

• Start date: 2017-06-24
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2023-10-04
• Last updated: 2025-02-20

Locations

1 site across 1 country: South Korea