Iliac Vein Stenting in Advanced Chronic Venous Insufficiency

Study Overview
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Brief Summary
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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 .

Official Title
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Randomized Double-blind Trial Between Clinical and Endovascular Treatment in Patients With Advanced Chronic Venous Insufficiency and Iliac Venous Obstruction

Conditions
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Iliac Vein Obstruction, May-Thurner Syndrome, Cockett Syndrome

Intervention / Treatment
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* Drug: Phlebotonic
* Device: Stent
* Procedure: Limb elastic compression support
* Procedure: Unna boot dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clinical Treatment<br>Phlebotonics: Aminaftone 75 mg BID Limb elastic compression support (Elastic stockings: Venosan / Elastic Bandages: Atamed) Unna boot dressing | Drug: Phlebotonic<br>* Aminaftone -- 75 mg BID<br>* Other names: Aminaftone;Procedure: Limb elastic compression support<br>* CEAP 3-5 > 20-30 mmHg compression stockings CEAP 6 > elastic bandages<br>* Other names: Atamed elastic bandages;Procedure: Unna boot dressing<br>* CEAP 6 > Unna boot dressing<br>|
| Active Comparator: Iliac vein stenting<br>Wallstent | Drug: Phlebotonic<br>* Aminaftone -- 75 mg BID<br>* Other names: Aminaftone;Device: Stent<br>* Iliac Vein Stenting<br>* Other names: Wallstent;Procedure: Limb elastic compression support<br>* CEAP 3-5 > 20-30 mmHg compression stockings CEAP 6 > elastic bandages<br>* Other names: Atamed elastic bandages;Procedure: Unna boot dressing<br>* CEAP 6 > Unna boot dressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pain on the Pain Visual Analogue Sacale at 6 months |  | 6 months | 
| Venous ulcer cicatrization at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Stent integrity at 6 months |  | 6 months | 
| Stent position at 6 months | Pelvic X-ray | 6 months | 
| Stent patency at 6 months | Stent patency obtained with treated venous segment Duplex Scanning | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iliac, Vein, Stent