Clinical Outcomes of GENOSS PCB for Femoropopliteal Artery Disease

This prospective, open-label, multicenter, observational study will enroll patients with femoropopliteal artery disease undergoing PTA with the GENOSS® PCB at 10 hospitals.

Because this is an observational study, the number of participants will not be calculated separately, but a total of 200 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.

Primary outcomes

• The primary safety endpoint [at 12 months post procedure]: 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 [at 12 months post procedure]: 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.

Secondary outcomes

• Target lesion revascularization (TLR, %) [at 1 month, 6 months, and 12 months post procedure]: 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 [at 1 month, 6 months, and 12 months post procedure]: Clinical improvement as assessed by changes in target limb Rutherford classification from baseline.
• Change in ABI (Ankle-brachial index) (or TBI (Toe-brachial index)) [at 1 month, 6 months, and 12 months post procedure]: Change in ABI (ankle-brachial index) from baseline
• Device success rate (%) [during the procedure]: 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).
• Procedural success rate (%) [immediately post procedure]: Procedural success is defined as residual stenosis of ≤ 50% by core laboratory.
• Clinical success rate (%) [up to 1 week]: Clinical success is defined as procedural success without complications (i.e. death, major target limb amputation, clinically-driven TLR) during the hospital stay post procedure.
• All-cause death (%) [at 12 months post procedure]
• Target vessel revascularization (TVR, %) [at 1 month, 6 months, and 12 months post procedure]
• Major target limb amputation (%) [at 12 months post procedure]: Major target limb amputation is defined as any amputation above the ankle on the target limb.

Sex: All, ages: 19 Years to 85 Years

<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.