NCT07158307

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Genoss Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This prospective, open-label, multicenter, observational study will enroll patients with de novo small coronary artery disease undergoing PCI with the GENOSS® DCB at 47 hospitals. Because this is an observational study, the number of participants will not be calculated separately, but a total of 3,000 participants are planned to be recruited during the study enrollment period. All patients will be followed up at 1, 2, and 3 years postprocedure to evaluate the safety and efficacy of the paclitaxel-coated PTCA balloon catheter.

Conditions

• Coronary Artery Disease(CAD)

Timeline

• Start date: 2024-06-27
• Primary completion: 2030-06-27
• Completion: 2031-06-30
• First posted: 2025-09-05
• Last updated: 2025-09-05

Locations

1 site across 1 country: South Korea