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)

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.

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.

<Inclusion criteria>

Enrollment in the study was limited to patients who met the following inclusion criteria:

1. Subject was ≥19 years of age.
2. Subject had target limb Rutherford classification 2, 3, 4 or 5.
3. Subjects with a stenosis of 70% or greater in the femoropopliteal artery.
4. 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.)
5. Subjects with a reference vessel diameter of ≥4 mm but ≤7 mm.
6. Subject provided written informed consent and was willing to comply with the study follow-up requirements.

<Exclusion criteria>

Patients were not permitted to enroll in the study if they met any of the following exclusion criteria:

1. Subjects was allergic to paclitaxel.
2. Subjects with contraindications or hypersensitivity to antiplatelet therapy.
3. Subject had life expectancy of less than 2 years.
4. Those who have undergone vascular surgery on the target lesion within the past 6 weeks.
5. Those who have in-stent restenosis (ISR) on the target lesion.
6. Those who have non-arteriosclerotic vascular disease, such as an aneurysm or vasculitis, on the target lesion.
7. Women who were pregnant, breast-feeding or intended to become pregnant.
8. Those who cannot perform pre-dilatation or who fail to apply the device, making it difficult to apply the device.
9. Those who have a Grade D or higher vascular dissection restricting blood flow after pre-dilatation or who require stent placement.
10. Those who, in the investigator's judgment, are not suitable for this study or may increase the risks associated with participation in the study.