Iliac Venous CompressionVIDIONCT02142062
Venogram vs. Intravascular Ultrasound (IVUS) for Diagnosing Iliac Vein Obstruction
An observational study of Iliac Venous Compression, run by Volcano Corporation at 14 sites in 4 countries.
Trial summary
The purpose of this study is to demonstrate that IVUS identifies more instances of significant iliac and common femoral vein outflow obstruction than multiplanar venography.No hypothesis testing is planned. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Iliac Venous Compression
- How many people
- 100 participants
- Where
- 14 sitesin 4 countries
- Study dates
- Jul 2014to Aug 2016
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with iliac compression disease CEAP classification 4-6. Hospitals, venous clinics
Who may be able to join
- Subject must be > 18 and < 85 years of age
- Willing to participate in and able to understand, read and sign the informed consent document before the planned procedure
- CEAP clinical classification: C4, C5, or C6 (enrollment of C4 and C5 subjects will be capped at 50, such that at least 50 C6 subjects can be enrolled)
- On duplex ultrasound: patent common femoral vein, and patent deep femoral vein, and/or femoral vein of the study leg
- Undergoing iliofemoral and inferior vena caval venography with the intent to treat obstructive lesions
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 metal allergy precluding endovascular stent implantation
- 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
Show all 15Show fewer
- Severe, untreated (and readily treatable) superficial venous reflux (great saphenous vein >7 mm in diameter, and/or small saphenous vein >4 mm in diameter)
- 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
- 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
14 sites in 4 countries.
14 sites in 4 countries
United States11 sites
University of Alabama
Birmingham, Alabama, 35924
Tufts Medical Center
Boston, Massachusetts, 02111
Allegheny Vein and Vascular Clinic
Bradford, Pennsylvania, 16701
Southern CT Vascular Center
Bridgeport, Connecticut, 06614
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599
Vein Center of Southwest Louisiana/Imperial Health
Lake Charles, Louisiana, 70601
The Mount Sinai Medical Center
New York, New York, 10029
Norwalk Hospital
Norwalk, Connecticut, 06856
Arizona Heart
Phoenix, Arizona, 85016
Washington University School of Medicine
St Louis, Missouri, 63110
SUNY Stony Brook University Medical Center
Stony Brook, New York, 11794
About this study
Official title: Prospective, Single-arm, Multi-center, Pilot Study of IVUS Imaging Used as an Adjunct to Multiplanar Venography During Iliac-common Femoral Vein Assessment for Possible Endovascular Intervention
The purpose of this study is to demonstrate that IVUS identifies more instances of significant iliac and common femoral vein outflow obstruction than multiplanar venography.No hypothesis testing is planned.
- Conditions
- Iliac Venous Compression
- Keywords
- Venous outflow obstruction, Iliac Vein, Common Femoral Vein, Iliac Compression
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 |
|---|---|---|
| Venography and IVUS imaging guiding treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
100 patients with Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) classification C4-6 undergoing iliac and common femoral and venography with intention to treat venous outflow obstruction.
Primary Endpoints: Both venous IVUS and traditional venography will provide measurements of minimum and maximum diameter reduction due to iliofemoral venous obstruction/compression; cross-sectional area reduction will also be measured by IVUS, and calculated for venography (from min. and max. diameters, assuming elliptical cross-section6). The diameters and cross-sectional area are compared to adjacent reference vessel in order to calculate the degree of stenosis. The percentage of significant stenosis detected at various thresholds [e.g., 50%, 60%, 70%, 80%, for diameter reduction, and (separately) for area reduction] 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. In addition to the binary outcome of significant stenosis, the numeric values for diameters and cross-sectional areas will be compared.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Iliac Venous CompressionStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volcano Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Gagne, M.D., Principal investigator, Southern Connecticut Vascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142062
- Sponsor's protocol ID
- 007-13
- Acronym
- VIDIO
- Status last verified
- Aug 2016
- First submitted
- 14 May 2014
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Murad MH, Coto-Yglesias F, Zumaeta-Garcia M, Elamin MB, Duggirala MK, Erwin PJ, Montori VM, Gloviczki P. A systematic review and meta-analysis of the treatments of varicose veins. J Vasc Surg. 2011 May;53(5 Suppl):49S-65S. doi: 10.1016/j.jvs.2011.02.031.
PubMed 21536173Bergan JJ, Schmid-Schonbein GW, Coleridge Smith PD, Nicolaides AN, Boisseau MR, Eklof B. Chronic venous disease. Minerva Cardioangiol. 2007 Aug;55(4):459-76. No abstract available. English, Italian.
PubMed 17653022Raju S, Neglen P. Clinical practice. Chronic venous insufficiency and varicose veins. N Engl J Med. 2009 May 28;360(22):2319-27. doi: 10.1056/NEJMcp0802444. No abstract available.
PubMed 19474429Neglen 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 11932665Raju S, Neglen P. High prevalence of nonthrombotic iliac vein lesions in chronic venous disease: a permissive role in pathogenicity. J Vasc Surg. 2006 Jul;44(1):136-43; discussion 144. doi: 10.1016/j.jvs.2006.02.065.
PubMed 16828437Murphy EH, Broker HS, Johnson EJ, Modrall JG, Valentine RJ, Arko FR 3rd. Device and imaging-specific volumetric analysis of clot lysis after percutaneous mechanical thrombectomy for iliofemoral DVT. J Endovasc Ther. 2010 Jun;17(3):423-33. doi: 10.1583/10-3088.1.
PubMed 20557187Raju S. Best management options for chronic iliac vein stenosis and occlusion. J Vasc Surg. 2013 Apr;57(4):1163-9. doi: 10.1016/j.jvs.2012.11.084. Epub 2013 Feb 20.
PubMed 23433816Alhalbouni S, Hingorani A, Shiferson A, Gopal K, Jung D, Novak D, Marks N, Ascher E. Iliac-femoral venous stenting for lower extremity venous stasis symptoms. Ann Vasc Surg. 2012 Feb;26(2):185-9. doi: 10.1016/j.avsg.2011.05.033. Epub 2011 Oct 22.
PubMed 22018502Vasquez MA, Rabe E, McLafferty RB, Shortell CK, Marston WA, Gillespie D, Meissner MH, Rutherford RB; American Venous Forum Ad Hoc Outcomes Working Group. Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American Venous Forum Ad Hoc Outcomes Working Group. J Vasc Surg. 2010 Nov;52(5):1387-96. doi: 10.1016/j.jvs.2010.06.161. Epub 2010 Sep 27.
PubMed 20875713Stacey MC, Burnand KG, Layer GT, Pattison M, Browse NL. Measurement of the healing of venous ulcers. Aust N Z J Surg. 1991 Nov;61(11):844-8. doi: 10.1111/j.1445-2197.1991.tb00169.x.
PubMed 1750819Eklof B, Rutherford RB, Bergan JJ, Carpentier PH, Gloviczki P, Kistner RL, Meissner MH, Moneta GL, Myers K, Padberg FT, Perrin M, Ruckley CV, Smith PC, Wakefield TW; American Venous Forum International Ad Hoc Committee for Revision of the CEAP Classification. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg. 2004 Dec;40(6):1248-52. doi: 10.1016/j.jvs.2004.09.027.
PubMed 15622385Gagne PJ, Gasparis A, Black S, Thorpe P, Passman M, Vedantham S, Marston W, Iafrati M. Analysis of threshold stenosis by multiplanar venogram and intravascular ultrasound examination for predicting clinical improvement after iliofemoral vein stenting in the VIDIO trial. J Vasc Surg Venous Lymphat Disord. 2018 Jan;6(1):48-56.e1. doi: 10.1016/j.jvsv.2017.07.009. Epub 2017 Oct 13.
PubMed 29033314Gagne PJ, Tahara RW, Fastabend CP, Dzieciuchowicz L, Marston W, Vedantham S, Ting W, Iafrati MD. Venography versus intravascular ultrasound for diagnosing and treating iliofemoral vein obstruction. J Vasc Surg Venous Lymphat Disord. 2017 Sep;5(5):678-687. doi: 10.1016/j.jvsv.2017.04.007. Epub 2017 Jun 28.
PubMed 28818221
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm, Multi-center, Pilot Study of IVUS Imaging Used as an Adjunct to Multiplanar Venography During Iliac-common Femoral Vein Assessment for Possible Endovascular Intervention
- ClinicalTrials.gov ID
- NCT02142062
- Acronym / sponsor ID
- VIDIO / 007-13
- Conditions
- Iliac Venous Compression
- Keywords
- Venous outflow obstruction, Iliac Vein, Common Femoral Vein, Iliac Compression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Volcano CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 20 May 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.
The purpose of this study is to demonstrate that IVUS identifies more instances of significant iliac and common femoral vein outflow obstruction than multiplanar venography.No hypothesis testing is planned.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venography and IVUS imaging guiding treatment | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with iliac compression disease CEAP classification 4-6. Hospitals, venous clinics
Key inclusion criteria (5 listed)
- Subject must be > 18 and < 85 years of age
- Willing to participate in and able to understand, read and sign the informed consent document before the planned procedure
- CEAP clinical classification: C4, C5, or C6 (enrollment of C4 and C5 subjects will be capped at 50, such that at least 50 C6 subjects can be enrolled)
- On duplex ultrasound: patent common femoral vein, and patent deep femoral vein, and/or femoral vein of the study leg
- Undergoing iliofemoral and inferior vena caval venography with the intent to treat obstructive lesions
Key exclusion criteria (15 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 metal allergy precluding endovascular stent implantation
- Known reaction or sensitivity to iodinated contrast that cannot be managed with premedication
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
100 patients with Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) classification C4-6 undergoing iliac and common femoral and venography with intention to treat venous outflow obstruction.
Time frame: 6 month
Primary Endpoints: Both venous IVUS and traditional venography will provide measurements of minimum and maximum diameter reduction due to iliofemoral venous obstruction/compression; cross-sectional area reduction will also be measured by IVUS, and calculated for venography (from min. and max. diameters, assuming elliptical cross-section6). The diameters and cross-sectional area are compared to adjacent reference vessel in order to calculate the degree of stenosis. The percentage of significant stenosis detected at various thresholds [e.g., 50%, 60%, 70%, 80%, for diameter reduction, and (separately) for area reduction] 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. In addition to the binary outcome of significant stenosis, the numeric values for diameters and cross-sectional areas will be compared.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Background: PubMed 21536173Murad MH, Coto-Yglesias F, Zumaeta-Garcia M, Elamin MB, Duggirala MK, Erwin PJ, Montori VM, Gloviczki P. A systematic review and meta-analysis of the treatments of varicose veins. J Vasc Surg. 2011 May;53(5 Suppl):49S-65S. doi: 10.1016/j.jvs.2011.02.031.
- Background: PubMed 17653022Bergan JJ, Schmid-Schonbein GW, Coleridge Smith PD, Nicolaides AN, Boisseau MR, Eklof B. Chronic venous disease. Minerva Cardioangiol. 2007 Aug;55(4):459-76. No abstract available. English, Italian.
- Background: PubMed 19474429Raju S, Neglen P. Clinical practice. Chronic venous insufficiency and varicose veins. N Engl J Med. 2009 May 28;360(22):2319-27. doi: 10.1056/NEJMcp0802444. No abstract available.
- 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 16828437Raju S, Neglen P. High prevalence of nonthrombotic iliac vein lesions in chronic venous disease: a permissive role in pathogenicity. J Vasc Surg. 2006 Jul;44(1):136-43; discussion 144. doi: 10.1016/j.jvs.2006.02.065.
- Background: PubMed 20557187Murphy EH, Broker HS, Johnson EJ, Modrall JG, Valentine RJ, Arko FR 3rd. Device and imaging-specific volumetric analysis of clot lysis after percutaneous mechanical thrombectomy for iliofemoral DVT. J Endovasc Ther. 2010 Jun;17(3):423-33. doi: 10.1583/10-3088.1.
- Background: PubMed 23433816Raju S. Best management options for chronic iliac vein stenosis and occlusion. J Vasc Surg. 2013 Apr;57(4):1163-9. doi: 10.1016/j.jvs.2012.11.084. Epub 2013 Feb 20.
- Background: PubMed 22018502Alhalbouni S, Hingorani A, Shiferson A, Gopal K, Jung D, Novak D, Marks N, Ascher E. Iliac-femoral venous stenting for lower extremity venous stasis symptoms. Ann Vasc Surg. 2012 Feb;26(2):185-9. doi: 10.1016/j.avsg.2011.05.033. Epub 2011 Oct 22.
- Background: PubMed 20875713Vasquez MA, Rabe E, McLafferty RB, Shortell CK, Marston WA, Gillespie D, Meissner MH, Rutherford RB; American Venous Forum Ad Hoc Outcomes Working Group. Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American Venous Forum Ad Hoc Outcomes Working Group. J Vasc Surg. 2010 Nov;52(5):1387-96. doi: 10.1016/j.jvs.2010.06.161. Epub 2010 Sep 27.
- Background: PubMed 1750819Stacey MC, Burnand KG, Layer GT, Pattison M, Browse NL. Measurement of the healing of venous ulcers. Aust N Z J Surg. 1991 Nov;61(11):844-8. doi: 10.1111/j.1445-2197.1991.tb00169.x.
- Background: PubMed 15622385Eklof B, Rutherford RB, Bergan JJ, Carpentier PH, Gloviczki P, Kistner RL, Meissner MH, Moneta GL, Myers K, Padberg FT, Perrin M, Ruckley CV, Smith PC, Wakefield TW; American Venous Forum International Ad Hoc Committee for Revision of the CEAP Classification. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg. 2004 Dec;40(6):1248-52. doi: 10.1016/j.jvs.2004.09.027.
- Derived from this study: PubMed 29033314Gagne PJ, Gasparis A, Black S, Thorpe P, Passman M, Vedantham S, Marston W, Iafrati M. Analysis of threshold stenosis by multiplanar venogram and intravascular ultrasound examination for predicting clinical improvement after iliofemoral vein stenting in the VIDIO trial. J Vasc Surg Venous Lymphat Disord. 2018 Jan;6(1):48-56.e1. doi: 10.1016/j.jvsv.2017.07.009. Epub 2017 Oct 13.
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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.
Paul Gagne, M.D. principal investigator
Southern Connecticut Vascular Center
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iliac Venous Compression, run by Volcano Corporation at 14 sites in 4 countries.
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 5 inclusion and 15 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: finished, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Italy, Poland, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100 patients with Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) classification C4-6 undergoing iliac and common femoral and venography with intention to treat venous outflow obstruction. (time frame: 6 month). 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 NCT02142062, which also lists 13 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 11 Aug 2016.