By InvitationNot Applicable

Clinical Outcomes of GENOSS PCB for Femoropopliteal Artery Disease

South Korea200 participantsStarted 2025-07-01

Plain-language 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.

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 IDNCT07399080

SponsorGenoss Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-06-30

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