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

Enrolling by invitation

Conditions studied: PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease

In brief

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.

Key facts

Study ID

NCT07431437

Run by

Genoss Co., Ltd.

People needed

300

Starts

2025-06-17

Expected to finish

2028-06-30

Last updated by the study team

2026-02-24

Who can join

Age: 19 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Enrollment in the study was limited to patients who met the following inclusion criteria:
• Subject was ≥19 years of age.
• Subject had target limb Rutherford classification 2, 3, 4 or 5.
• Subject with femoropopliteal artery disease who underwent percutaneous transluminal angioplasty using the GENOSS PCB.
• At least one patent native ouflow artery to the ankle of foot, free from significant stenosis (≥50% stenosis) as confirmed by angiography.
• Subject provided written informed consent and was willing to comply with the study follow-up requirements.

You may not qualify if…

• Patients were not permitted to enroll in the study if they met any of the following exclusion criteria:
• Subjects was allergic to paclitaxel.
• Subjects with contraindications or hypersensitivity to antiplatelet therapy.
• Subject had life expectancy of less than 2 years.
• Women who were pregnant, breast-feeding or intended to become pregnant.
• Subject was participating in another investigational drug or medical device study.
• Subject was unwilling or unable to comply with procedures specified in the protocol or had difficulty or inability to return for follow-up visits as specified by the protocol.

Where it is running

• Korea University Guro Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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