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.
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 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.
Patients with long femoropopliteal lesions who underwent percutaneous angioplasty using GENOSS PCB
Cohort
Prospective
Not listed
The primary safety endpoint
The primary safety endpoint is the Major Adverse Events (MAEs)-free rate, defined as a composite of freedom from all-cause death through 1month post procedure and/or freedom from both major target limb amputation and/or clinically-driven target lesion revascularization (TLR) through 12months post procedure.
The primary effectiveness endpoint
The primary effectiveness endpoint is a primary patency, defined as a composite of freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from binary restenosis (restenosis defined as peak systolic velocity ratio \[PSVR\] ≥ 2.4 assessed by duplex ultrasound or ≥ 50% stenosis as assessed by CT angiography) through 12months post procedure.
Target lesion revascularization (TLR, %)
TLR is defined as any re-intervention within the target lesion due to symptoms or drop of ABI/TBI of ≥ 20% or \> 0.15 when compared to post procedure baseline.
Change in Rutherford classification
Clinical improvement as assessed by changes in target limb Rutherford classification from baseline.
Change in ABI (Ankle-brachial index) (or TBI (Toe-brachial index))
Change in ABI (ankle-brachial index) from baseline
Device success rate (%)
Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).
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