Clinical Trial

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

Name: Safety and Efficacy of GENOSS® DCB With a Shellac Plus Vitamin E Excipient in Patients With De Novo Lesion — clinical trial record (NCT07158307)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: PCB-De Novo

Enrolling by Invitation

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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.

Trial Details

NCT Number	NCT07158307
Lead Sponsor	Genoss Co., Ltd.
Conditions	Coronary Artery Disease(CAD)
Enrollment	3,000 participants
Start Date	2024-06-27
Primary Completion	2030-06-27 (estimated)
Study Completion	2031-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-05