Randomized Double-blind Trial Between Clinical and Endovascular Treatment in Patients With Advanced Chronic Venous Insufficiency and Iliac Venous Obstruction
Overview
- Phase
- Phase 4
- Intervention
- Phlebotonic
- Conditions
- Iliac Vein Obstruction
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Venous ulcer cicatrization at 6 months
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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 .
Investigators
Fabio H Rossi
PHD
Instituto Dante Pazzanese de Cardiologia
Eligibility Criteria
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
Arms & Interventions
Clinical Treatment
Phlebotonics: Aminaftone 75 mg BID Limb elastic compression support (Elastic stockings: Venosan / Elastic Bandages: Atamed) Unna boot dressing
Intervention: Phlebotonic
Clinical Treatment
Phlebotonics: Aminaftone 75 mg BID Limb elastic compression support (Elastic stockings: Venosan / Elastic Bandages: Atamed) Unna boot dressing
Intervention: Limb elastic compression support
Clinical Treatment
Phlebotonics: Aminaftone 75 mg BID Limb elastic compression support (Elastic stockings: Venosan / Elastic Bandages: Atamed) Unna boot dressing
Intervention: Unna boot dressing
Iliac vein stenting
Wallstent
Intervention: Phlebotonic
Iliac vein stenting
Wallstent
Intervention: Stent
Iliac vein stenting
Wallstent
Intervention: Limb elastic compression support
Iliac vein stenting
Wallstent
Intervention: Unna boot dressing
Outcomes
Primary Outcomes
Venous ulcer cicatrization at 6 months
Time Frame: 6 months
Change from baseline in pain on the Pain Visual Analogue Sacale at 6 months
Time Frame: 6 months
Secondary Outcomes
- 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)