Iliac Vein Stenting in Advanced Chronic Venous Insufficiency

Phase 4

Completed

• Conditions: Cockett Syndrome; Iliac Vein Obstruction; May-Thurner Syndrome
• Interventions: Drug: Phlebotonic; Procedure: Limb elastic compression support; Device: Stent; Procedure: Unna boot dressing

• Registration Number: NCT02149212
• Lead Sponsor: Instituto Dante Pazzanese de Cardiologia

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2014-05-25
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-05-29
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-22
• Last Update Posted: 2014-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iliac vein stenting	Phlebotonic	Wallstent
Clinical Treatment	Phlebotonic	Phlebotonics: Aminaftone 75 mg BID Limb elastic compression support (Elastic stockings: Venosan / Elastic Bandages: Atamed) Unna boot dressing
Clinical Treatment	Limb elastic compression support	Phlebotonics: Aminaftone 75 mg BID Limb elastic compression support (Elastic stockings: Venosan / Elastic Bandages: Atamed) Unna boot dressing
Clinical Treatment	Unna boot dressing	Phlebotonics: Aminaftone 75 mg BID Limb elastic compression support (Elastic stockings: Venosan / Elastic Bandages: Atamed) Unna boot dressing
Iliac vein stenting	Unna boot dressing	Wallstent
Iliac vein stenting	Stent	Wallstent
Iliac vein stenting	Limb elastic compression support	Wallstent

Primary Outcome Measures

Name	Time	Method
Venous ulcer cicatrization at 6 months	6 months
Change from baseline in pain on the Pain Visual Analogue Sacale at 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Stent integrity at 6 months	6 months
Stent position at 6 months	6 months	Pelvic X-ray
Stent patency at 6 months	6 months	Stent patency obtained with treated venous segment Duplex Scanning
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

Trial Locations

Locations (1)

Instituto Dante Pazzanese de Cardilogia; 🇧🇷 São Paulo, Sao Paulo, Brazil