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ENROLLING BY INVITATION
NCT06086496

Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent (GENOSS® DES)

Sponsor: Genoss Co., Ltd.

View on ClinicalTrials.gov

Summary

In this study, the investigators evaluated the effectiveness and safety of using the GENOSS® DES, which has a biodegradable polymer only on the inner wall of the blood vessel, for patients(all-comers) with coronary artery disease who require percutaneous coronary intervention through stent insertion.

Official title: Evaluation of Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent in Routine Clinical Practice: A Prospective, Single-arm, Multicenter, Observational Study (The GENCOMX Registry)

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2022-07-15

Completion Date

2027-12-31

Last Updated

2025-10-06

Healthy Volunteers

No

Interventions

DEVICE

GENOSS® DES Sirolimus Eluting Coronary Stent System

The GENOSS® DES is L-605 cobalt chromium (CoCr) platform with a strut thickness of 70µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.

Locations (1)

Korea University Anam Hospital

Seoul, Seoul, South Korea