Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-85
SponsorGenoss Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

300 Participants
are grouped into 1 trial group

Sponsors and collaborators