Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 92
- 主要终点
- Composite Rate of Major Adverse Events
研究概览
简要总结
Study of the OffRoad™ Re-entry Catheter System for subintimal recanalization of chronic total occlusions in native femoropopliteal arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Claudication or critical limb ischemia (Rutherford Category 2-5)
- •Documented de novo or re-occluded Chronic Total Occlusion (CTO) (99-100% stenosed) lesion in native femoropopliteal artery
- •Target vessel occlusion length is ≥ 1 cm and ≤ 30 cm
- •Minimum reference vessel diameter is 4 mm
排除标准
- •Contraindication to an endovascular procedure
- •Previous stent placement in the target vessel
- •Prior surgery of the superficial femoral artery (SFA) in the target limb to treat atherosclerotic disease
- •Platelet count <150,000 mm3 or >600,000 mm3
- •Renal insufficiency with a serum creatinine >2.3 mg/dl
- •History of major amputation (ankle level or above) in the same limb as the target lesion
- •Current participation in another drug or device clinical study
结局指标
主要结局
Composite Rate of Major Adverse Events
时间窗: 30 days
Composite rate of major adverse events (MAEs) related to the OffRoad System at 30 days, including: death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above). Events are based on data adjudicated by a Clinical Event Committee.
Effectiveness (On the Day of Procedure)
时间窗: Device technical success is determined during the index procedure, from the time of first puncture of the skin in order to obtain access to the artery until the time the introducer sheath is removed from the body
Device Technical Success rate, defined as placement of a guidewire in the true lumen distal to a Chronic Total Occlusion (CTO)
次要结局
未报告次要终点