One-Year Results of GENOSS PCB (Paclitaxel-coated Balloon With a Shellac Plus Vitamin E Excipient) Real-World Study in Femoropopliteal Artery Disease: A Prospective, Multicenter, Observational Study (GENOSS PCB-F/P)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The primary safety endpoint
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB by enrolling and tracking patients who underwent percutaneous transluminal angioplasty using GENOSS PCB in patients with femoropopliteal artery disease.
详细描述
This prospective, multicenter, single-arm, observational study will enroll patients with femoropopliteal artery disease undergoing PTA with the GENOSS® PCB at 6 hospitals.
Because this is an observational study, the number of participants will not be calculated separately, but a total of 300 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrollment in the study was limited to patients who met the following inclusion criteria:
- •Subject was ≥19 years of age.
- •Subject had target limb Rutherford classification 2, 3, 4 or
- •Subject with femoropopliteal artery disease who underwent percutaneous transluminal angioplasty using the GENOSS PCB.
- •At least one patent native ouflow artery to the ankle of foot, free from significant stenosis (≥50% stenosis) as confirmed by angiography.
- •Subject provided written informed consent and was willing to comply with the study follow-up requirements.
排除标准
- •Patients were not permitted to enroll in the study if they met any of the following exclusion criteria:
- •Subjects was allergic to paclitaxel.
- •Subjects with contraindications or hypersensitivity to antiplatelet therapy.
- •Subject had life expectancy of less than 2 years.
- •Women who were pregnant, breast-feeding or intended to become pregnant.
- •Subject was participating in another investigational drug or medical device study.
- •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.
研究组 & 干预措施
GENOSS® Peripheral DCB PTA Catheter
Patient treated with GENOSS PCB in the femoropopliteal artery disease
结局指标
主要结局
The primary safety endpoint
时间窗: 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
时间窗: 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.
次要结局
- Change in Rutherford classification(at 1 month, 6 months, and 12 months post procedure)
- Target lesion revascularization (TLR, %)(at 1 month, 6 months, and 12 months post procedure)
- Device success rate (%)(during the procedure)
- Change in ABI (Ankle-brachial index) (or TBI (Toe-brachial index))(at 1 month, 6 months, and 12 months post procedure)
- Procedural success rate (%)(immediately post procedure)
- Clinical success rate (%)(up to 1 week)
- 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)