Determination Of Effectiveness Of Directional Atherectomy Followed By A Paclitaxel- Coated Balloon For The Treatment Of Infrainguinal Vessels With Long Occlusive Femoropopliteal Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Peak Systolic Velocity Ratio (PSVR)
研究概览
简要总结
The study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the UltrafreeTM drug coated balloon catheter versus the drug coated balloon in patients with chronic long femoropopliteal lesions.
详细描述
This is a multicenter, prospective, randomized, controlled comparison study. A total of 100 subjects will be enrolled into this study and will be randomized on a 1:1 basis to either drug coated balloon angioplasty combined with atherectomy or drug coated balloon angioplasty for subjects with long de-nove or restenosis femoropopliteal lesions( Stenotic lesion>15cm or Chronic total occlusion between 6-15cm). Angiographic patterns of the target lesion, including lesion length, calcification grade, and minimal lumen diameter (MLD) prior to and after the intervention, ultrasound images of the target lesion at 12-month follow-up will be independently adjudicated by an independent angiographic and ultrasound core lab. The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. Follow-up visits are scheduled at 1,3,6,12,24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be between 18 and 85 years old;
- •Chronic, symptomatic lower limb ischemia defined as Rutherford categories 3-5;
- •Stenotic, restenosis, or occlusive lesions in the native femoropopliteal artery which meets all of the following criteria: Stenotic lesion(>70% diameter stenosis) >15cm or Chronic total occlusion between 6-15cm; Target vessel is 3.0 to 7.0 mm in diameter (visual estimate); Guidewire must be across the target lesion within the true lumen before study randomization;
- •Patent distal popliteal artery and at least one patent distal runoff;
- •Willing to comply with the follow-up evaluation;
- •Written informed consent prior to any study procedures.
排除标准
- •Women during pregnancy and lactation, or patients with baby planning;
- •Life expectancy<2 years;
- •Target lesion/vessel with in-stent restenosis
- •Target restenosis/vessel lesion previously treated with drug coated balloon or atherectomy <12 months
- •Subjects s who are currently participating in other interventional drug or device trials;
- •Angiographic evidence of thrombus within the target vessel
- •Subjects have a history of stroke within 3 months;
- •Subjects have a history of myocardial infarction, thrombolytic therapy, or angina pectoris within 2 weeks;
- •Concomitant Renal failure with a serum creatinine>2.0mg/dl; Subjects with known allergy to heparin, low molecular weight heparin, and contrast agents.
结局指标
主要结局
Peak Systolic Velocity Ratio (PSVR)
时间窗: 12-month
Peak Systolic Velocity Ratio (PSVR) of target lesion measured by ultrasound (PSVR ≤2.4 means primary patent of target lesion)
Freedom from major adverse limb events（MALEs）
时间窗: 12-month
Freedom from flow-limiting dissections (D-F), clinically-driven target vessel revascularization, major amputation, and all-cause of death
次要结局
- EuroQol five dimensions questionnaire (EQ 5D-5L) score(24-month)
- Technical success(Immediately after endovascular treatment)
- Quality of life score(24-month)
- Procedural success(During the hospital stay)
- Primary sustained clinical improvement(24-month)