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ENROLLING BY INVITATION
NCT07158307

Safety and Efficacy of GENOSS® DCB With a Shellac Plus Vitamin E Excipient in Patients With De Novo Lesion

Sponsor: Genoss Co., Ltd.

View on ClinicalTrials.gov

Summary

The GENOSS PCB-De Novo study aims to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter containing shellac and vitamin E excipients (Genoss® DCB) in patients with De novo small coronary artery disease.

Official title: Safety and Efficacy of Paclitaxel-coated PTCA Balloon Catheter With a Shellac Plus Vitamin E Excipient (GENOSS® DCB) in Patients With De Novo Lesion of Small Coronary Artery Disease: A Prospective, Multi-center, Observational Study

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

3000

Start Date

2024-06-27

Completion Date

2031-06-30

Last Updated

2025-09-05

Healthy Volunteers

No

Locations (1)

Ulsan University Hospital

Ulsan, South Korea