Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vascular Ultrasound Versus Intravascular Ultrasound for Diagnosing Iliac Vein Obstruction (USG-DIVO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02240914
Recruitment Status : Unknown
Verified September 2014 by Fabio H Rossi, Instituto Dante Pazzanese de Cardiologia.
Recruitment status was:  Recruiting
First Posted : September 16, 2014
Last Update Posted : September 16, 2014
Sponsor:
Collaborators:
Instituto Dante Pazzanese de Cardiologia
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Fabio H Rossi, Instituto Dante Pazzanese de Cardiologia

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).

Condition or disease
Iliac Vein Obstruction May-Thurner Syndrome Cockett Syndrome

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
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
Study Start Date : February 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort
Vascular USG and IVUS imaging diagnosis



Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with iliac compression disease CEAP classification 3-6.
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 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
  • Venous outflow obstruction caused by tumor thrombus
  • Life expectancy of less than 6 months
  • Lower Extremity Arterial Insufficiency
  • Elevated baseline blood creatinine (value greater than the upper limit of the normal range)
  • Any concurrent disease or condition that, in the opinion of the Investigator, would make the subject unsuitable for participation in the study; examples include but are not limited to the inability to lie supine for the index procedure (e.g., severe congestive heart failure), thrombocytopenia or other hematological disorders associated with an unacceptable risk of bleeding, implanted orthopedic hardware that precludes proper imaging, etc.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240914


Locations
Layout table for location information
Brazil
Instituto Dante Pazzanese de Cardiologia Recruiting
São Paulo, Brazil, 04012-909
Contact: Patrick B Metzger, MD    (011)50856060 ext 55    patrickvascular@gmail.com   
Principal Investigator: Patrick B Metzger, MD         
Sponsors and Collaborators
Fabio H Rossi
Instituto Dante Pazzanese de Cardiologia
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Layout table for investigator information
Principal Investigator: Patrick B Metzger, MD Vascular Surgeon

Additional Information:

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Fabio H Rossi, PHD, Instituto Dante Pazzanese de Cardiologia
ClinicalTrials.gov Identifier: NCT02240914     History of Changes
Other Study ID Numbers: IDPC_ 4 2014
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014
Keywords provided by Fabio H Rossi, Instituto Dante Pazzanese de Cardiologia:
Iliac Vein Obstruction
May-Thurner Syndrome
Cockett Syndrome
Vascular Ultrasound
IVUS
Additional relevant MeSH terms:
Layout table for MeSH terms
May-Thurner Syndrome
Syndrome
Disease
Pathologic Processes
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases
Congenital Abnormalities