NCT07399080

Clinical Outcomes of GENOSS PCB for Femoropopliteal Artery Disease

Real-World Clinical Outcomes of GENOSS PCB (Paclitaxel-coated Balloon) for Femoropopliteal Artery Disease: A Prospective, Multicenter, Observational Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Genoss Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The GENOSS PCB study aims to evaluate the safety and efficacy of a Paclitaxel-coated PTA Balloon Catheter(GENOSS® PCB) in patients with the femoropopliteal artery disease.

Detailed description

This prospective, open-label, multicenter, observational study will enroll patients with femoropopliteal artery disease undergoing PTA with the GENOSS® PCB at 10 hospitals. Because this is an observational study, the number of participants will not be calculated separately, but a total of 200 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: 2025-07-01
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2026-02-10
• Last updated: 2026-02-18

Locations

1 site across 1 country: South Korea