NCT05448625

Genoss DES in Patients With a High Risk of Ischemic Events (GENTLE Registry)

Safety and Efficacy of Sirolimus-eluting Biodegradable Abluminal Coating Stents in Patients With a High Risk of Ischemic Events: a Single-center, Prospective, Observational Trial (GENTLE Registry)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective cohort study to evaluate the long-term effect and safety of Genoss drug-eluting stents (DES) in patients with coronary artery disease with high ischemic features.

Detailed description

It is known that ischemic events after percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) increase as the anatomical, physiological, or functional complexity of coronary artery disease increases. Recently, the concept of complex higher-risk and clinically indented procedure (CHIP) has been proposed, which includes patients with various medical conditions, patients with various heart conditions, and patients with technically complex PCI. Until now, Genoss stents have no data on the evaluation of stents in patients with coronary artery disease and high ischemic features.

Conditions

• Drug-eluting Stent
• Coronary Artery Disease

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: 2022-05-26
• Primary completion: 2025-05-14
• Completion: 2025-09-23
• First posted: 2022-07-07
• Last updated: 2025-11-25

Locations

1 site across 1 country: South Korea