NCT02149212

Iliac Vein Stenting in Advanced Chronic Venous Insufficiency

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Instituto Dante Pazzanese de Cardiologia · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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 .

Conditions

• Iliac Vein Obstruction
• May-Thurner Syndrome
• Cockett Syndrome

Interventions

Type	Name	Description
DRUG	Phlebotonic	Aminaftone -- 75 mg BID
DEVICE	Stent	Iliac Vein Stenting
PROCEDURE	Limb elastic compression support	CEAP 3-5 \> 20-30 mmHg compression stockings CEAP 6 \> elastic bandages
PROCEDURE	Unna boot dressing	CEAP 6 \> Unna boot dressing

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-05-29
• Last updated: 2014-07-23

Locations

1 site across 1 country: Brazil