Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System
概览
- 阶段
- 不适用
- 干预措施
- BlueLeaf System
- 疾病 / 适应症
- Chronic Venous Insufficiency
- 发起方
- Intervene, Inc.
- 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.
- 状态
- 终止
- 最后更新
- 9天前
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.
研究者
入排标准
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;
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
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)