Safety and Effectiveness of GENOSS PCB (Paclitaxel-coated Balloon) in Patients With Long Femoropopliteal Lesion: A Prospective, Multicenter, Observational Study (GENOSS-PCB Long)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 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 in patients with long femoropopliteal lesions who underwent percutaneous transluminal angioplasty using GENOSS PCB.
详细描述
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.
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
- •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 with a reference vessel diameter of ≥4 mm but ≤7 mm.
- •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.
- •Those who have undergone vascular surgery on the target lesion within the past 6 weeks.
- •Those who have in-stent restenosis (ISR) on the target lesion.
- •Those who have non-arteriosclerotic vascular disease, such as an aneurysm or vasculitis, on the target lesion.
- •Women who were pregnant, breast-feeding or intended to become pregnant.
- •Those who cannot perform pre-dilatation or who fail to apply the device, making it difficult to apply the device.
- •Those who have a Grade D or higher vascular dissection restricting blood flow after pre-dilatation or who require stent placement.
- •Those who, in the investigator's judgment, are not suitable for this study or may increase the risks associated with participation in the study.
研究组 & 干预措施
GENOSS® Peripheral DCB PTA Catheter
Patients with long femoropopliteal artery disease treated with the GENOSS paclitaxel-coated balloon (PCB)
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
- Target lesion revascularization (TLR, %)(at 1 month, 6 months, and 12 months post procedure)
- Change in Rutherford classification(at 1 month, 6 months, and 12 months post procedure)
- Change in ABI (Ankle-brachial index) (or TBI (Toe-brachial index))(at 1 month, 6 months, and 12 months post procedure)
- Device success rate (%)(during the 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)