A Non-randomized Study of the Avinger Ocelot System Used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 17
- 主要终点
- Primary Efficacy Endpoint
研究概览
简要总结
Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing totally occluded femoropopliteal arteries.
详细描述
The purpose of this clinical study is to evaluate the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing chronic total occlusions (CTOs) in femoropopliteal arteries. The Ocelot Catheter is a minimally invasive percutaneous device that is designed to traverse arterial occlusions through the use of spiral wedges contained in the distal tip of the device. The device is also equipped with an OCT (optical coherence tomography) imaging fiber that provides directional orientation and an intravascular view of the vessel wall and target lesion. The Ocelot Catheter is used in conjunction with standard endovascular devices and as an adjunct to fluoroscopic guidance.
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
- •Patient is willing and able to provide informed consent
- •Patient is willing and able to comply with the study protocol
- •Patient is > 18 years old
- •Patient has peripheral arterial disease requiring revascularization as evidenced by CTA, MRA or angiography
- •Patient has an occluded femoropopliteal artery that is 99-100% stenosed and is ≥ 1 cm and ≤ 30 cm in length by visual estimate
- •Target vessel is ≥ 3.0 mm in diameter
- •Patient has Rutherford Classification of 2-5
- •Lesion is recalcitrant to guidewire crossing
排除标准
- •Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated
- •Patient has a known sensitivity or allergy to aspirin, heparin or anti-platelet medications
- •Patient is pregnant or lactating
- •Patient has a co-existing disease or medical condition contraindicating percutaneous intervention
- •Target vessel is severely calcified as evidenced by angiography
- •Target lesion is in a bypass graft
- •Target lesion is in a stent (i.e., in-stent restenosis)
- •Patient has had a procedure on the target limb within 7 days
- •Patient has had a procedure on the target limb within the past 30 days and is unstable
- •Patient has a planned surgical or interventional procedure within 30 days after the study procedure
- •Patient is simultaneously participating in an investigational device study for treatment of peripheral vascular disease
- •Patient has a planned amputation of the target limb
- •Patient has a history of bleeding diathesis, coagulopathy or will refuse blood transfusion in cases of emergency
研究组 & 干预措施
Ocelot System
CTO crossing in femoropopliteal arteries using the Ocelot System
干预措施: CTO crossing in femoropopliteal arteries CONNECT II (Device)
结局指标
主要结局
Primary Efficacy Endpoint
时间窗: Day 0
Successful femoropopliteal CTO crossing using the Ocelot System as identified by guidewire placement in the distal true lumen confirmed by angiography.
Primary Safety Endpoint
时间窗: Day 30
No evidence of in-hospital MAEs, 30 day MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Ocelot System CTO crossing confirmed by angiography.
次要结局
- Procedural Success(Day 0)
- Fluoroscopic Time(Day 0)
- Procedural Time(Day 0)
- Technical Success(Day 0)
- CTO Crossing Time(Day 0)
- Use of Assist Devices(Day 0)
- Device Performance(Day 0)
- Contrast/Flush Volumes(Day 0)