Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion (NCT07425171) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion
South Korea300 participantsStarted 2026-02-24
Plain-language 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.
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.
✓. Subjects with a stenosis of 70% or greater in the femoropopliteal artery.
✓. Subjects with a stenotic or occlusive lesion measuring ≥150 mm in total length. (Multiple adjacent lesions separated by less than 3 cm from angiographically healthy segments are treated as a single lesion.)
✓. Subjects with a reference vessel diameter of ≥4 mm but ≤7 mm.
✓. 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.
✕. Those who have undergone vascular surgery on the target lesion within the past 6 weeks.
✕. Those who have in-stent restenosis (ISR) on the target lesion.
✕. Those who have non-arteriosclerotic vascular disease, such as an aneurysm or vasculitis, on the target lesion.
✕. Women who were pregnant, breast-feeding or intended to become pregnant.