Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 10
- 主要终点
- Freedom from target vessel deep venous thrombosis (DVT) at the 30-day follow-up imaging study.
研究概览
简要总结
To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).
详细描述
Prospective, non-randomized, multicenter pre-market feasibility study to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic CVI of the lower extremity. The BlueLeaf System is designed to form autogenous tissue leaflets from vein walls in the femoral and popliteal veins without the use of a permanent vascular implant for the treatment of CVI. Subjects meeting eligibility criteria will be enrolled and may be followed through 5 years post treatment.
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
- •Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) grade 3 to 6;
- •Failed compression therapy of at least 6 months' duration;
- •Deep system venous reflux characterized by >1 second reflux time;
- •Presence of at least one target site within the target vessel.
排除标准
- •Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms;
- •Deep venous intervention in the target limb or outflow vessels within 6 months of consent;
- •Significant peripheral arterial disease with an ankle-brachial index of <0.50 or with incompressible vessels;
- •Acute deep venous thrombosis (DVT) within 3 months of consent;
- •History of stroke within the last 6 months;
- •Flow-limiting venous outflow obstruction central to the intended target sites;
- •Insufficient inflow through the treatment vein upon manual augmentation;
- •Chronic, diffuse, post-thrombotic femoropopliteal vein disease that, in the Investigator's opinion, would preclude venous valve formation or would inhibit flow through the treatment sites;
- •Chronic renal insufficiency with creatinine level of ≥2mg/dL;
- •Hemoglobin level <9.0 mg/dL;
- •Platelet count <50,000 or >1,000,000 per mm3;
- •Total white blood cell count <3,000/mm3;
- •Pregnant or lactating female; positive pregnancy test, women of childbearing potential must be tested;
- •Non-ambulatory patients;
研究组 & 干预措施
BlueLeaf System
The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.
干预措施: BlueLeaf System (Device)
结局指标
主要结局
Freedom from target vessel deep venous thrombosis (DVT) at the 30-day follow-up imaging study.
时间窗: 30 days
Percent decrease in reflux time (RT) in the primary treated vein segment from pre-procedure baseline to the 30-day follow-up imaging study
时间窗: 30 days
Primary Effectiveness: Change in Reflux Time (RT) in the Primary Treated Vein Segment
时间窗: Baseline, 7-day, 30-day
Change in reflux time (reported as % change) in the primary treated vessel from pre-procedure baseline compared to the 30-day follow-up
Primary Safety: Number of Participants With Target Vessel Deep Venous Thrombosis (DVT)
时间窗: 30-day post-procedure
Rates (count) of participant with DVTs in the target vessel at the 30-day time point - analyzed for subjects that completed the 30-day follow-up visit
次要结局
- Number of Participants With Target Vessel Deep Venous Thrombosis (DVT) in the Primary Treated Vein Segment(90-day, 210-day)
- Change in Reflux Time (RT) in the Primary Treated Vein Segment(90-day, 210-day)