Clinical Trial: Vascular Ultrasound Versus Intravascular Ultrasound for Diagnosing Iliac Vein Obstruction

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational [Patient Registry]

Official Title: Prospective, Single-arm, Single Center, Pilot Study of Vascular Ultrasound Imaging Used as an Adjunct to Intravascular Ultrasound for Diagnosing Iliac Vein Obstruction

Brief Summary:

  • Determine the sensitivity, specificity and accuracy of vascular ultrasound, using direct and indirect ultrasonographic signs, in the obstructive diseases of iliac venous segment, in patients with advanced chronic venous insufficiency (CEAP 3-6), considering the intravascular ultrasound (IVUS) as the gold standard for this diagnosis.
  • Develop an algorithm for noninvasive ultrasound investigation of obstructive lesions in the iliac segment in patients with advanced chronic venous insufficiency (CEAP 3-6).

Detailed Summary:
Sponsor: Fabio H Rossi

Current Primary Outcome: A composite of direct and indirect ultrasonographic signs as a measure of iliac vein stenosis [ Time Frame: within 15 days ]

• 50 patients with Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) classification C3-6 undergoing iliac and common femoral vascular ultrasound imaging with intention to detect significative iliac vein obstructions ( > 50%) and this results will be compared with the gold standard method - IVUS. Primary Endpoints: venous imaging in B- mode, volume flow and expiratory velocity in femoral vein, and the velocity relation before and through the stenosis provided by vascular ultrasound will be analyzed. Venous IVUS will provide measurements of minimum and maximum diameter reduction due to iliofemoral venous obstruction/compression; cross-sectional area reduction will also be measured.

The percentage of significant stenosis detected at various thresholds [ < 50%, 50-80%,> 80%] with each method will be compared in a pair-wise fashion. This will be done with descriptive statistics of the detection rates for each method, and the rate of discordance between the two.



Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Instituto Dante Pazzanese de Cardiologia

Dates:
Date Received: September 3, 2014
Date Started: February 2013
Date Completion: December 2014
Last Updated: September 13, 2014
Last Verified: September 2014