Iliac Vein ObstructionUSG-DIVONCT02240914
Vascular Ultrasound Versus Intravascular Ultrasound for Diagnosing Iliac Vein Obstruction
An observational study of Iliac Vein Obstruction and May-Thurner Syndrome, run by Fabio H Rossi at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Iliac Vein Obstruction, May-Thurner Syndrome, Cockett Syndrome
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2013to Dec 2014
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with iliac compression disease CEAP classification 3-6.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04012-909
Patrick B Metzger, MD, (011)50856060 ext. 55, patrickvascular@gmail.com
Patrick B Metzger, MD
About this study
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
- 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).
- Keywords
- Iliac Vein Obstruction, May-Thurner Syndrome, Cockett Syndrome, Vascular Ultrasound, IVUS
- Medical subject headings
- May-Thurner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vascular USG and IVUS imaging diagnosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of direct and indirect ultrasonographic signs as a measure of iliac vein stenosis
- 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.
Measured: within 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startFeb 2013
- Primary completionNov 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Iliac Vein ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fabio H Rossi
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Dante Pazzanese de Cardiologia, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor-investigator, Fabio H Rossi, Instituto Dante Pazzanese de Cardiologia
- Investigators
- Patrick B Metzger, MD, Principal investigator, Vascular Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240914
- Sponsor's protocol ID
- IDPC_ 4 2014
- Acronym
- USG-DIVO
- Status last verified
- Sep 2014
- First submitted
- 3 Sep 2014
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
MAY R, THURNER J. The cause of the predominantly sinistral occurrence of thrombosis of the pelvic veins. Angiology. 1957 Oct;8(5):419-27. doi: 10.1177/000331975700800505. No abstract available.
PubMed 13478912Cockett FB, Thomas ML. The iliac compression syndrome. Br J Surg. 1965 Oct;52(10):816-21. doi: 10.1002/bjs.1800521028. No abstract available.
PubMed 5828716Marston W, Fish D, Unger J, Keagy B. Incidence of and risk factors for iliocaval venous obstruction in patients with active or healed venous leg ulcers. J Vasc Surg. 2011 May;53(5):1303-8. doi: 10.1016/j.jvs.2010.10.120. Epub 2011 Jan 7.
PubMed 21215568Etufugh CN, Phillips TJ. Venous ulcers. Clin Dermatol. 2007 Jan-Feb;25(1):121-30. doi: 10.1016/j.clindermatol.2006.09.004.
PubMed 17276209McGuckin M, Waterman R, Brooks J, Cherry G, Porten L, Hurley S, Kerstein MD. Validation of venous leg ulcer guidelines in the United States and United Kingdom. Am J Surg. 2002 Feb;183(2):132-7. doi: 10.1016/s0002-9610(01)00856-x.
PubMed 11918875Lin EP, Bhatt S, Rubens D, Dogra VS. The importance of monophasic Doppler waveforms in the common femoral vein: a retrospective study. J Ultrasound Med. 2007 Jul;26(7):885-91. doi: 10.7863/jum.2007.26.7.885.
PubMed 17592051Neglen P, Raju S. Intravascular ultrasound scan evaluation of the obstructed vein. J Vasc Surg. 2002 Apr;35(4):694-700. doi: 10.1067/mva.2002.121127.
PubMed 11932665Labropoulos N, Borge M, Pierce K, Pappas PJ. Criteria for defining significant central vein stenosis with duplex ultrasound. J Vasc Surg. 2007 Jul;46(1):101-7. doi: 10.1016/j.jvs.2007.02.062. Epub 2007 May 30.
PubMed 17540535Virchow R. Uber die erweiterung kleiner gefasse. Arch Path Anat. 1851; 3:427.
Malgor RD, Adrahtas D, Spentzouris G, Gasparis AP, Tassiopoulos AK, Labropoulos N. The role of duplex ultrasound in the workup of pelvic congestion syndrome. J Vasc Surg Venous Lymphat Disord. 2014 Jan;2(1):34-8. doi: 10.1016/j.jvsv.2013.06.004. Epub 2013 Sep 24.
PubMed 26992966Malgor RD, Labropoulos N. Diagnosis of venous disease with duplex ultrasound. Phlebology. 2013 Mar;28 Suppl 1:158-61. doi: 10.1177/0268355513476653.
PubMed 23482553Raju S, Hollis K, Neglen P. Obstructive lesions of the inferior vena cava: clinical features and endovenous treatment. J Vasc Surg. 2006 Oct;44(4):820-7. doi: 10.1016/j.jvs.2006.05.054. Epub 2006 Aug 22.
PubMed 16926084Metzger PB, Rossi FH, Fernandez MG, de Carvalho SFC, Metzger SL, Izukawa NM, Kambara AM, Thorpe P. Association between the degree of iliac venous outflow obstruction by intravascular ultrasound and lower limb venous reflux. J Vasc Surg Venous Lymphat Disord. 2023 Sep;11(5):1004-1013.e1. doi: 10.1016/j.jvsv.2023.05.018. Epub 2023 Jun 21.
PubMed 37353155Metzger PB, Rossi FH, Kambara AM, Izukawa NM, Saleh MH, Pinto IM, Amorim JE, Thorpe PE. Criteria for detecting significant chronic iliac venous obstructions with duplex ultrasound. J Vasc Surg Venous Lymphat Disord. 2016 Jan;4(1):18-27. doi: 10.1016/j.jvsv.2015.07.002. Epub 2015 Sep 12.
PubMed 26946891
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02240914
- Acronym / sponsor ID
- USG-DIVO / IDPC_ 4 2014
- Keywords
- Iliac Vein Obstruction, May-Thurner Syndrome, Cockett Syndrome, Vascular Ultrasound, IVUS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fabio H RossiUniversity, hospital or other
- Collaborators
- Instituto Dante Pazzanese de Cardiologia, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vascular USG and IVUS imaging diagnosis | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with iliac compression disease CEAP classification 3-6.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
- Background: PubMed 13478912MAY R, THURNER J. The cause of the predominantly sinistral occurrence of thrombosis of the pelvic veins. Angiology. 1957 Oct;8(5):419-27. doi: 10.1177/000331975700800505. No abstract available.
- Background: PubMed 5828716Cockett FB, Thomas ML. The iliac compression syndrome. Br J Surg. 1965 Oct;52(10):816-21. doi: 10.1002/bjs.1800521028. No abstract available.
- Background: PubMed 21215568Marston W, Fish D, Unger J, Keagy B. Incidence of and risk factors for iliocaval venous obstruction in patients with active or healed venous leg ulcers. J Vasc Surg. 2011 May;53(5):1303-8. doi: 10.1016/j.jvs.2010.10.120. Epub 2011 Jan 7.
- Background: PubMed 17276209Etufugh CN, Phillips TJ. Venous ulcers. Clin Dermatol. 2007 Jan-Feb;25(1):121-30. doi: 10.1016/j.clindermatol.2006.09.004.
- Background: PubMed 11918875McGuckin M, Waterman R, Brooks J, Cherry G, Porten L, Hurley S, Kerstein MD. Validation of venous leg ulcer guidelines in the United States and United Kingdom. Am J Surg. 2002 Feb;183(2):132-7. doi: 10.1016/s0002-9610(01)00856-x.
- Background: PubMed 17592051Lin EP, Bhatt S, Rubens D, Dogra VS. The importance of monophasic Doppler waveforms in the common femoral vein: a retrospective study. J Ultrasound Med. 2007 Jul;26(7):885-91. doi: 10.7863/jum.2007.26.7.885.
- Background: PubMed 11932665Neglen P, Raju S. Intravascular ultrasound scan evaluation of the obstructed vein. J Vasc Surg. 2002 Apr;35(4):694-700. doi: 10.1067/mva.2002.121127.
- Background: PubMed 17540535Labropoulos N, Borge M, Pierce K, Pappas PJ. Criteria for defining significant central vein stenosis with duplex ultrasound. J Vasc Surg. 2007 Jul;46(1):101-7. doi: 10.1016/j.jvs.2007.02.062. Epub 2007 May 30.
- Results publicationVirchow R. Uber die erweiterung kleiner gefasse. Arch Path Anat. 1851; 3:427.
- Results publication: PubMed 26992966Malgor RD, Adrahtas D, Spentzouris G, Gasparis AP, Tassiopoulos AK, Labropoulos N. The role of duplex ultrasound in the workup of pelvic congestion syndrome. J Vasc Surg Venous Lymphat Disord. 2014 Jan;2(1):34-8. doi: 10.1016/j.jvsv.2013.06.004. Epub 2013 Sep 24.
- Results publication: PubMed 23482553Malgor RD, Labropoulos N. Diagnosis of venous disease with duplex ultrasound. Phlebology. 2013 Mar;28 Suppl 1:158-61. doi: 10.1177/0268355513476653.
- Results publication: PubMed 16926084Raju S, Hollis K, Neglen P. Obstructive lesions of the inferior vena cava: clinical features and endovenous treatment. J Vasc Surg. 2006 Oct;44(4):820-7. doi: 10.1016/j.jvs.2006.05.054. Epub 2006 Aug 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
Patrick B Metzger, MD principal investigator
Vascular Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iliac Vein Obstruction and May-Thurner Syndrome, run by Fabio H Rossi at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of direct and indirect ultrasonographic signs as a measure of iliac vein stenosis (time frame: within 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02240914, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2014.