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

One-Year Results of GENOSS PCB (Paclitaxel-coated Balloon With a Shellac Plus Vitamin E Excipient) Real-World Study in Femoropopliteal Artery Disease: A Prospective, Multicenter, Observational Study (GENOSS PCB-F/P)

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.

This prospective, multicenter, single-arm, observational study will enroll patients with femoropopliteal artery disease undergoing PTA with the GENOSS® PCB at 6 hospitals.

Because this is an observational study, the number of participants will not be calculated separately, but a total of 300 participants are planned to be recruited during the study period.

All patients will be followed up at 12 months postprocedure to evaluate the safety and efficacy of the paclitaxel-coated PTA balloon catheter.

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. Subject with femoropopliteal artery disease who underwent percutaneous transluminal angioplasty using the GENOSS PCB.
4. At least one patent native ouflow artery to the ankle of foot, free from significant stenosis (≥50% stenosis) as confirmed by angiography.
5. 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. Women who were pregnant, breast-feeding or intended to become pregnant.
5. Subject was participating in another investigational drug or medical device study.
6. 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.