Randomized Double-blind Trial Between Clinical and Endovascular Treatment in Patients With Advanced Chronic Venous Insufficiency and Iliac Venous Obstruction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Venous ulcer cicatrization at 6 months
研究概览
简要总结
About 90 % of vascular symptoms affecting the lower limbs consist of venous diseases. Its highest incidence occurs from the second decade of life, affecting significantly the economically active population. Chronic Venous Insufficiency treatment aims to relieve symptoms, treat and prevent complications, prevent recurrences and provide cosmetic satisfaction with minimal side effects. It's current treatment includes some classic postural measures (leg elevation), elastic stockings and bandages compression therapy and possible medication (phlebotonics). The results in the medium and long term are unfavorable, since a large number of patients do not get better or evolves with recurrence of symptoms. Nowadays many, no prospective , not randomized , international studies have shown favorable results with endovascular treatment of obstruction in the iliac vein territory in patients with advanced Chronic Venous Insufficiency . The purpose of this prospective, double-blinded randomized study is to evaluate the results obtained with endovascular treatment, through the use of angioplasty and stenting in this group of patients when compared with clinical treatment .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Advanced Chronic Venous Insufficiency (CEAP 3-6) submitted to clinical treatment for at least 1 year with no response.
- •Subject must be > 18 and < 80 years of age
- •Willing to participate in and able to understand, read and sign the informed consent document before the planned procedure
- •On duplex ultrasound: patent common femoral vein, and patent deep femoral vein, and/or femoral vein of the study leg
排除标准
- •Subject cannot or will not provide written informed consent
- •Previous venous stent implantation involving the study leg or inferior vena cava
- •Previous venovenous bypass surgery involving the study leg
- •Known metal allergy precluding endovascular stent implantation
- •Known reaction or sensitivity to iodinated contrast that cannot be managed with premedication
- •Subjects who are pregnant (women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment
- •Acute deep venous thrombosis involving either leg
- •Known history of chronic total occlusion of the common femoral vein of the study leg.
- •Known history of thrombophilia (e.g., protein C or S deficiency, anti-thrombin III deficiency, presence of lupus anticoagulant, etc.)
- •Venous compression caused by tumor encasement
- •Venous outflow obstruction caused by tumor thrombus
- •Life expectancy of less than 6 months
- •Lower Extremity Arterial Insufficiency
- •Elevated baseline blood creatinine (value greater than the upper limit of the normal range)
- •Any concurrent disease or condition that, in the opinion of the Investigator, would make the subject unsuitable for participation in the study; examples include but are not limited to the inability to lie supine for the index procedure (e.g., severe congestive heart failure), thrombocytopenia or other hematological disorders associated with an unacceptable risk of bleeding, implanted orthopedic hardware that precludes proper imaging, etc.
研究组 & 干预措施
Clinical Treatment
Phlebotonics: Aminaftone 75 mg BID Limb elastic compression support (Elastic stockings: Venosan / Elastic Bandages: Atamed) Unna boot dressing
干预措施: Phlebotonic (Drug)
Clinical Treatment
Phlebotonics: Aminaftone 75 mg BID Limb elastic compression support (Elastic stockings: Venosan / Elastic Bandages: Atamed) Unna boot dressing
干预措施: Limb elastic compression support (Procedure)
Clinical Treatment
Phlebotonics: Aminaftone 75 mg BID Limb elastic compression support (Elastic stockings: Venosan / Elastic Bandages: Atamed) Unna boot dressing
干预措施: Unna boot dressing (Procedure)
Iliac vein stenting
Wallstent
干预措施: Phlebotonic (Drug)
Iliac vein stenting
Wallstent
干预措施: Stent (Device)
Iliac vein stenting
Wallstent
干预措施: Limb elastic compression support (Procedure)
Iliac vein stenting
Wallstent
干预措施: Unna boot dressing (Procedure)
结局指标
主要结局
Venous ulcer cicatrization at 6 months
时间窗: 6 months
Change from baseline in pain on the Pain Visual Analogue Sacale at 6 months
时间窗: 6 months
次要结局
- Stent integrity at 6 months(6 months)
- Stent position at 6 months(6 months)
- Stent patency at 6 months(6 months)
- Change from the baseline Venous Clinical Severity Score at 6 month(6 months)
- Change from baseline in SF-36 Quality of Life questionnaire at 6 months(6 months)
研究者
Fabio H Rossi
PHD
Instituto Dante Pazzanese de Cardiologia