May-thurner SyndromeNCT02584374
Balloon Test for Iliac Vein Compression
An observational study of May-thurner Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Iliac vein compression is a common cause of leg or abdominal complaints and is difficult to diagnose. Although a combination of duplex ultrasonography, magnetic resonance venography and two-plane phlebography are able to show compression, not all suspected iliac vein compressions can be identified. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- May-thurner Syndrome
- What is being tested?
- Venography with balloon occlusion test
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2016to Mar 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers (all patients who have been diagnosed using this technique will be used as a comparison group)
Who may be able to join
- Healthy volunteers (all patients who have been diagnosed using this technique will be used as a comparison group)
Who cannot join
- Disease affecting the circulatory system, such as cardiac disease, varicosities or peripheral arterial disease, on the basis of anamnesis.
- History of bleeding or clotting disorders
- Complaints of the abdomen or leg consistent with iliac vein compression syndrome or pelvic congestion syndrome
- Clinical-Etiologic-Anatomic-Pathophysiologic classification of C2 or higher (C0: no venous signs, C1: venectasia, C2: varicose veins, C3: edema, C4: skin changes, C5 healed ulcer, C6: active ulcer)
- History of deep venous thrombosis or pulmonary embolism.
- History of surgery of the abdomen, groin or lower limb
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- Pregnancy
- Allergy to contrast or lidocaine
- Active malignancy
- (For the patient comparison group: obvious signs of compression on venography without balloon occlusion test)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Centre+
Maastricht
R Kurstjens
About this study
Iliac vein compression is a common cause of leg or abdominal complaints and is difficult to diagnose. Although a combination of duplex ultrasonography, magnetic resonance venography and two-plane phlebography are able to show compression, not all suspected iliac vein compressions can be identified. Intravascular ultrasound appears to have a higher diagnostic value, but is far more expensive. In our experience a balloon occlusion test in the common iliac vein during phlebography can diagnose iliac vein compression due to the collateral network that is visualised. The general consensus is that pelvic collaterals are a sign of pathology, though the investigators would like to validate this test by showing that a balloon occlusion test in healthy subjects does not identify a collateral network.
Read the detailed description
Rationale: Iliac vein compression is a common cause of leg or abdominal complaints and is difficult to diagnose. Although a combination of duplex ultrasonography, magnetic resonance venography and two-plane phlebography are able to show compression, not all suspected iliac vein compressions can be identified. Intravascular ultrasound appears to have a higher diagnostic value, but is far more expensive. In the investigators' experience a balloon occlusion test in the common iliac vein during phlebography can diagnose iliac vein compression due to the collateral network that is visualised. The general consensus is that pelvic collaterals are a sign of pathology, though the investigators would like to validate this test by showing that a balloon occlusion test in healthy subjects does not identify a collateral network.
Objective: The objective of this study is to identify whether venography with balloon occlusion of the common iliac vein has value in the diagnosis of iliac vein compression syndrome.
Study design: This is an observational study in healthy subjects compared to a patient population with suspected iliac vein compression.
Study population: Healthy subjects between the ages of 18 and 45 and patients with suspected iliac vein compression who show no signs of compression on venography.
Diagnostic test: Subjects will undergo a diagnostic phlebography, during which the common iliac vein is occluded by balloon inflation and contrast is injected to identify whether a network of pelvic collaterals will appear.
Main study parameters/endpoints: The main endpoint of this study is the presence of collaterals that cross the midline after balloon occlusion of the left common iliac vein, which is scored as present or not Additionally, a quantitive analysis of collaterals will be performed.
- Conditions
- May-thurner Syndrome
- Being tested
- Venography with balloon occlusion test
- Keywords
- iliac vein compression
- 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.
Venography with balloon occlusion testOther
First, regular venography of the venous iliac tract will be performed. Second, a 16mm diameter balloon will be inflated in the common iliac vein and venography will be repeated.
| Study group | Role | What they receive |
|---|---|---|
| Patients | with suspected iliac vein compression, but with no signs of compression on venography and if venography with balloon occlusion test is performed. Receives: Other: Venography with balloon occlusion test | |
| Healthy controls | Healthy subjects between 18-45 years of age
Venography with balloon occlusion test will be performed. Receives: Other: Venography with balloon occlusion test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of collaterals (prevalence number)
During regular venography the presence and amount of collaterals are scored. Collaterals need to cross the midline to be considered positive. Subsequently, balloon occlusion of the left common iliac vein will be performed and another contrast injection will take place. The presence and amount of collaterals will again be assessed. Quantitive analysis will be performed to evaluate the amount of collaterals and how they are branched off.
Measured: During venography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for May-thurner SyndromeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- R de Graaf, MD, PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584374
- Sponsor's protocol ID
- NL54330
- Status last verified
- Oct 2015
- First submitted
- 20 Oct 2015
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Test for Iliac Vein Compression
- ClinicalTrials.gov ID
- NCT02584374
- Acronym / sponsor ID
- NL54330
- Conditions
- May-thurner Syndrome
- Keywords
- iliac vein compression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 22 Oct 2015 (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.
Iliac vein compression is a common cause of leg or abdominal complaints and is difficult to diagnose. Although a combination of duplex ultrasonography, magnetic resonance venography and two-plane phlebography are able to show compression, not all suspected iliac vein compressions can be identified. Intravascular ultrasound appears to have a higher diagnostic value, but is far more expensive. In our experience a balloon occlusion test in the common iliac vein during phlebography can diagnose iliac vein compression due to the collateral network that is visualised. The general consensus is that pelvic collaterals are a sign of pathology, though the investigators would like to validate this test by showing that a balloon occlusion test in healthy subjects does not identify a collateral network.
Detailed description
Rationale: Iliac vein compression is a common cause of leg or abdominal complaints and is difficult to diagnose. Although a combination of duplex ultrasonography, magnetic resonance venography and two-plane phlebography are able to show compression, not all suspected iliac vein compressions can be identified. Intravascular ultrasound appears to have a higher diagnostic value, but is far more expensive. In the investigators' experience a balloon occlusion test in the common iliac vein during phlebography can diagnose iliac vein compression due to the collateral network that is visualised. The general consensus is that pelvic collaterals are a sign of pathology, though the investigators would like to validate this test by showing that a balloon occlusion test in healthy subjects does not identify a collateral network.
Objective: The objective of this study is to identify whether venography with balloon occlusion of the common iliac vein has value in the diagnosis of iliac vein compression syndrome.
Study design: This is an observational study in healthy subjects compared to a patient population with suspected iliac vein compression.
Study population: Healthy subjects between the ages of 18 and 45 and patients with suspected iliac vein compression who show no signs of compression on venography.
Diagnostic test: Subjects will undergo a diagnostic phlebography, during which the common iliac vein is occluded by balloon inflation and contrast is injected to identify whether a network of pelvic collaterals will appear.
Main study parameters/endpoints: The main endpoint of this study is the presence of collaterals that cross the midline after balloon occlusion of the left common iliac vein, which is scored as present or not Additionally, a quantitive analysis of collaterals will be performed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Venography with balloon occlusion testwith suspected iliac vein compression, but with no signs of compression on venography and if venography with balloon occlusion test is performed. |
| Healthy controls | – | Other: Venography with balloon occlusion testHealthy subjects between 18-45 years of age Venography with balloon occlusion test will be performed. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers (all patients who have been diagnosed using this technique will be used as a comparison group)
Key inclusion criteria (1 listed)
- Healthy volunteers (all patients who have been diagnosed using this technique will be used as a comparison group)
Key exclusion criteria (10 listed)
- Disease affecting the circulatory system, such as cardiac disease, varicosities or peripheral arterial disease, on the basis of anamnesis.
- History of bleeding or clotting disorders
- Complaints of the abdomen or leg consistent with iliac vein compression syndrome or pelvic congestion syndrome
- Clinical-Etiologic-Anatomic-Pathophysiologic classification of C2 or higher (C0: no venous signs, C1: venectasia, C2: varicose veins, C3: edema, C4: skin changes, C5 healed ulcer, C6: active ulcer)
- History of deep venous thrombosis or pulmonary embolism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venography with balloon occlusion testFirst, regular venography of the venous iliac tract will be performed. Second, a 16mm diameter balloon will be inflated in the common iliac vein and venography will be repeated. | Other | Healthy controls, Patients |
Primary outcome
Presence of collaterals (prevalence number)
Time frame: During venography
During regular venography the presence and amount of collaterals are scored. Collaterals need to cross the midline to be considered positive. Subsequently, balloon occlusion of the left common iliac vein will be performed and another contrast injection will take place. The presence and amount of collaterals will again be assessed. Quantitive analysis will be performed to evaluate the amount of collaterals and how they are branched off.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
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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.
R de Graaf, MD, PhD principal investigator
Maastricht UMC
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 May-thurner Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
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 1 inclusion and 10 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 22 Jan 2016. 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 Netherlands. 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?
Contact Ralph LM Kurstjens, MD (+31433881558, r.kurstjens@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of collaterals (prevalence number) (time frame: During venography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2016; AzTrials last refreshed its copy on 28 Oct 2026.