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Iliac Vein Stenting in Advanced Chronic Venous Insufficiency

NCT02149212 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-07-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Instituto Dante Pazzanese de Cardiologia

    lead OTHER

Principal Investigators

  • Fabio H Rossi, PHD · Instituto Dante Pazzanese de Cardiologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02149212 on ClinicalTrials.gov