A Prospective, Non-randomized Study to Evaluate the Safety and Performance of the NovaCross™ Microcatheter in Femoropopliteal Chronic Total Occlusion (CTO).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Major Adverse Events
研究概览
简要总结
Trial is to evaluate the safety and performance of the NovaCross™micro-catheter in respect to providing additional guidewire support that is expected to allow easier crossing of femoropopliteal and infra-popliteal Chronic Total Occlusion (CTO) lesion. The procedure will be conducted on a patient diagnosed with a CTO in a peripheral vessel that requires revascularization.
详细描述
This is an open label, single center, prospective, first in man pilot study in which the investigational device, NitiLoop micro-catheter, will be tested in up to 15 patients with symptomatic peripheral arterial occlusive disease scheduled to undergo CTO in an anterograde approach.
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
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult aged 25-80
- •Patient understands and has signed the study informed consent form.
- •Patient has symptomatic peripheral artery disease (PAD) requiring endovascular revascularization of a CTO, evidenced by angiography, computed tomography or magnetic resonance angiography.
- •Patient has an occluded femoropopliteal or infra popliteal artery
- •Target femoropopliteal or infra-popliteal vessel is ≥ 2.5 mm and ≤5 mm in diameter.
- •Patient has Rutherford-Becker Classification of 2-5.
排除标准
- •Patient unable to give informed consent.
- •Current participation in another study with any investigational drug or device.
- •Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated.
- •Patient has a known sensitivity or allergy to anti-platelet medications.
- •Patient is pregnant or lactating.
- •Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.
- •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 had undergone attempted treatment of the CTO within the prior 3 months (to prevent a guidewire from entering dissection planes created by prior recanalization attempts.
- •Vasculitis and Buerger disease (thrombendarteritis obliterans)
- •Evidence of embolism
- •Peripheral vessel aneurysm
结局指标
主要结局
Major Adverse Events
时间窗: 30 days
absence of in-hospital or 30-days Major Adverse Events (MAEs)
Device success is defined as successful delivery, crossing, and retrieval of the investigational device as identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography
时间窗: in procedure
Successful femoropopliteal/infra popliteal CTO crossing using the NovaCross™ micro-catheter
次要结局
未报告次要终点