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.
This is a prospective, multicenter, single-arm, observational study designed to evaluate the long-term safety and effectiveness of the GENOSS paclitaxel-coated balloon (PCB) in patients with long femoropopliteal artery lesions treated with percutaneous transluminal angioplasty (PTA). The study will enroll patients who undergo PTA using the GENOSS PCB at 4 hospitals. Approximately 300 patients are planned to be enrolled during the study period. All enrolled patients will be followed for 12 months after the index procedure to assess the long-term safety and effectiveness of the GENOSS PCB. Additionally, the primary endpoints, major adverse event-free rate and primary patency, will be assessed during follow-up.
Study Type
OBSERVATIONAL
Enrollment
300
Ajou University Hospital
Suwon, Gyeonggi-do, 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 rate (%)
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