Clinical Trial: Iliac Vein Stenting in Advanced Chronic Venous Insufficiency

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Instituto Dante Pazzanese de Cardiologia

Current Primary Outcome:

  • Change from baseline in pain on the Pain Visual Analogue Sacale at 6 months [ Time Frame: 6 months ]
  • Venous ulcer cicatrization at 6 months [ Time Frame: 6 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from the baseline Venous Clinical Severity Score at 6 month [ Time Frame: 6 months ]
  • Change from baseline in SF-36 Quality of Life questionnaire at 6 months [ Time Frame: 6 months ]
  • Stent integrity at 6 months [ Time Frame: 6 months ]
  • Stent position at 6 months [ Time Frame: 6 months ]
    Pelvic X-ray
  • Stent patency at 6 months [ Time Frame: 6 months ]
    Stent patency obtained with treated venous segment Duplex Scanning


Original Secondary Outcome: Same as current

Information By: Instituto Dante Pazzanese de Cardiologia

Dates:
Date Received: May 25, 2014
Date Started: February 2013
Date Completion:
Last Updated: July 22, 2014
Last Verified: July 2014