NCT07431437

One-Year Results of GENOSS PCB Real-World Study in Femoropopliteal Artery Disease

One-Year Results of GENOSS PCB (Paclitaxel-coated Balloon With a Shellac Plus Vitamin E Excipient) Real-World Study in Femoropopliteal Artery Disease: A Prospective, Multicenter, Observational Study (GENOSS PCB-F/P)

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Genoss Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: —

Summary

The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB by enrolling and tracking patients who underwent percutaneous transluminal angioplasty using GENOSS PCB in patients with femoropopliteal artery disease.

Detailed description

This prospective, multicenter, single-arm, observational study will enroll patients with femoropopliteal artery disease undergoing PTA with the GENOSS® PCB at 6 hospitals. Because this is an observational study, the number of participants will not be calculated separately, but a total of 300 participants are planned to be recruited during the study period. All patients will be followed up at 12 months postprocedure to evaluate the safety and efficacy of the paclitaxel-coated PTA balloon catheter.

Conditions

• PTA (Percutaneous Transluminal Angioplasty)
• Femoropopliteal Artery Disease

Timeline

• Start date: 2025-06-17
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2026-02-24
• Last updated: 2026-02-24

Locations

1 site across 1 country: South Korea