The GENOSS PCB study aims to evaluate the safety and efficacy of a Paclitaxel-coated PTA Balloon Catheter(GENOSS® PCB) in patients with the 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.
Study Type
OBSERVATIONAL
Enrollment
200
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
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.
Time frame: at 12 months 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.
Time frame: at 12 months 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.
Time frame: at 1 month, 6 months, and 12 months post procedure
Change in Rutherford classification
Clinical improvement as assessed by changes in target limb Rutherford classification from baseline.
Time frame: at 1 month, 6 months, and 12 months post procedure
Change in ABI (Ankle-brachial index) (or TBI (Toe-brachial index))
Change in ABI (ankle-brachial index) from baseline
Time frame: at 1 month, 6 months, and 12 months post procedure
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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Time frame: during the procedure
Procedural success rate (%)
Procedural success is defined as residual stenosis of ≤ 50% by core laboratory.
Time frame: immediately post procedure
Clinical success
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.
Time frame: up to 1 week
All-cause death (%)
Time frame: at 12 months post procedure
Target vessel revascularization (TVR, %)
Time frame: at 1 month, 6 months, and 12 months post procedure
Major target limb amputation (%)
Major target limb amputation is defined as any amputation above the ankle on the target limb.
Time frame: at 12 months post procedure