By InvitationNot Applicable

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

South Korea300 participantsStarted 2025-06-17

Plain-language 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.

Who can participate

Age range19 Years – 85 Years

SexALL

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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.

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.

What they're measuring

The primary safety endpoint

Timeframe: at 12 months post procedure

The primary effectiveness endpoint

Timeframe: at 12 months post procedure

Trial details

NCT IDNCT07431437

SponsorGenoss Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-06-30

View on ClinicalTrials.gov More PTA (Percutaneous Transluminal Angioplasty) trials