First-in-man Study to Assess Efficacy and Safety of a Novel Titanium-Nitride Coated Woven-nitinol Peripheral Arterial Stent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- In-stent binary restenosis of the treated segment
研究概览
简要总结
The GoldenFlow (Lifetech Scientific, Shenzhen, China) is a novel woven-nitinol stent designed to have superior radial strength, flexibility and durability compared to standard nitinol stents for femoropopliteal lesions. This is a first-in-man study to evaluate the safety and efficacy of GoldenFlow woven-nitinol stent for intraluminal treatment of peripheral vascular disease in the femoropopliteal arteries.
详细描述
Endovascular treatment in femoropopliteal segment is the most challenging area due to restenosis and stent fracture after endovascular treatment. The titanium-nitride coated woven-nitinol peripheral arterial stent system (GoldenFlow, Lifetech Science, Shenzhen, China) is designed to have superior radial strength, flexibility and durability to withstand the compression, torsion, bending, lengthening and shortening found in femoropopliteal disease. Compared to another commercially available woven-nitinol stent, the GoldenFlow stent has the potential advantage to be repositionable and is less likely to lengthen during deployment. This is a first-in-man study is to evaluate the safety and efficacy of GoldenFlow woven-nitinol stent for intraluminal treatment of peripheral vascular disease in de-novo femoropopliteal lesions.
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
- •Age ≥18 years
- •Symptomatic leg ischemia (Rutherford class 2 to 4)
- •Ankle Brachial Index <0.9
- •De novo femoropopliteal stenosis (≥70%) or occlusion
- •Reference diameter 4 and 7mm
- •Lesion length 4 to 15cm
- •At least one patent (<50% stenosis) infrapopliteal run-off vessel
- •The lesion(s) can be successfully crossed with a guidewire and dilated
- •Patients with bilateral femoropopliteal disease is eligible for enrollment into the study
- •Staged contralateral limb procedure can be performed >30 days after index procedure
- •Able to provide written informed consent and willing to comply with specified follow-up evaluation schedule
排除标准
- •Tissue loss or gangrene (Rutherford class 5 and 6)
- •Previous bypass surgery or stenting in target vessel
- •Untreated aortoiliac or common femoral artery inflow disease >50%
- •Intervention of ipsilateral lesions during the index procedure or staged intervention within 30 days after index procedure
研究组 & 干预措施
GoldenFlow stent
Titanium nitrite coated woven nitinol stent
干预措施: GoldenFlow Stent (Device)
结局指标
主要结局
In-stent binary restenosis of the treated segment
时间窗: at 6 month
Determined by Duplex ultrasound
次要结局
- Stent fracture(6 months)
- Clinically driven target vessel revascularization(6 months)
- Technical Success(intraoperation)
- Safety Outcomes as assessed by composite of death, index limb amputation and ischemic driven target vessel revacularization(30 days)
研究者
Professor Bryan Ping Yen YAN
Professor
Chinese University of Hong Kong