Trials / Not Yet Recruiting
Not Yet RecruitingNCT07425171
Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion
Safety and Effectiveness of GENOSS PCB (Paclitaxel-coated Balloon) in Patients With Long Femoropopliteal Lesion: A Prospective, Multicenter, Observational Study (GENOSS-PCB Long)
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Genoss Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB in patients with long femoropopliteal lesions who underwent percutaneous transluminal angioplasty using GENOSS PCB.
Detailed description
This is a prospective, multicenter, single-arm, observational study designed to evaluate the long-term safety and effectiveness of the GENOSS paclitaxel-coated balloon (PCB) in patients with long femoropopliteal artery lesions treated with percutaneous transluminal angioplasty (PTA). The study will enroll patients who undergo PTA using the GENOSS PCB at 4 hospitals. Approximately 300 patients are planned to be enrolled during the study period. All enrolled patients will be followed for 12 months after the index procedure to assess the long-term safety and effectiveness of the GENOSS PCB. Additionally, the primary endpoints, major adverse event-free rate and primary patency, will be assessed during follow-up.
Conditions
- PTA (Percutaneous Transluminal Angioplasty)
- Femoropopliteal Artery Disease
- Long Femoropopliteal Artery Disease
Timeline
- Start date
- 2026-02-24
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
- First posted
- 2026-02-20
- Last updated
- 2026-02-20
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT07425171. Inclusion in this directory is not an endorsement.