Iliac Vein ObstructionPhase 4NCT02149212
Iliac Vein Stenting in Advanced Chronic Venous Insufficiency
A Phase 4 study testing Phlebotonic, Stent and Limb elastic compression support in people with Iliac Vein Obstruction and May-Thurner Syndrome, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.
Trial summary
About 90 % of vascular symptoms affecting the lower limbs consist of venous diseases. Its highest incidence occurs from the second decade of life, affecting significantly the economically active population. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Iliac Vein Obstruction, May-Thurner Syndrome, Cockett Syndrome
- What is being tested?
- Phlebotonic, Stent and Limb elastic compression support
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2013to Jul 2014
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
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 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
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Dante Pazzanese de Cardilogia
São Paulo, São Paulo, 04012-909
About this study
Official title: Randomized Double-blind Trial Between Clinical and Endovascular Treatment in Patients With Advanced Chronic Venous Insufficiency and Iliac Venous Obstruction
About 90 % of vascular symptoms affecting the lower limbs consist of venous diseases. Its highest incidence occurs from the second decade of life, affecting significantly the economically active population. Chronic Venous Insufficiency treatment aims to relieve symptoms, treat and prevent complications, prevent recurrences and provide cosmetic satisfaction with minimal side effects. It's current treatment includes some classic postural measures (leg elevation), elastic stockings and bandages compression therapy and possible medication (phlebotonics). The results in the medium and long term are unfavorable, since a large number of patients do not get better or evolves with recurrence of symptoms. Nowadays many, no prospective , not randomized , international studies have shown favorable results with endovascular treatment of obstruction in the iliac vein territory in patients with advanced Chronic Venous Insufficiency . The purpose of this prospective, double-blinded randomized study is to evaluate the results obtained with endovascular treatment, through the use of angioplasty and stenting in this group of patients when compared with clinical treatment .
- Being tested
- Phlebotonic, Stent, Limb elastic compression support, Unna boot dressing
- Keywords
- Iliac, Vein, Stent
- 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.
PhlebotonicDrug
Also called Aminaftone
Aminaftone -- 75 mg BID
StentDevice
Also called Wallstent
Iliac Vein Stenting
Limb elastic compression supportProcedure or surgery
Also called Venosan compression stockings, Atamed elastic bandages
CEAP 3-5 > 20-30 mmHg compression stockings CEAP 6 > elastic bandages
Unna boot dressingProcedure or surgery
CEAP 6 > Unna boot dressing
| Study group | Role | What they receive |
|---|---|---|
| Clinical Treatment | Active comparator | Phlebotonics: Aminaftone 75 mg BID Limb elastic compression support (Elastic stockings: Venosan / Elastic Bandages: Atamed) Unna boot dressing Receives: Drug: Phlebotonic; Procedure: Limb elastic compression support; Procedure: Unna boot dressing |
| Iliac vein stenting | Active comparator | Wallstent Receives: Drug: Phlebotonic; Device: Stent; Procedure: Limb elastic compression support; Procedure: Unna boot dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain on the Pain Visual Analogue Sacale at 6 months
Measured: 6 months
Venous ulcer cicatrization at 6 months
Measured: 6 months
Secondary outcomes (5)
Change from the baseline Venous Clinical Severity Score at 6 month
Measured: 6 months
Change from baseline in SF-36 Quality of Life questionnaire at 6 months
Measured: 6 months
Stent integrity at 6 months
Measured: 6 months
Stent position at 6 months
Pelvic X-ray
Measured: 6 months
Stent patency at 6 months
Stent patency obtained with treated venous segment Duplex Scanning
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startFeb 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Dante Pazzanese de Cardiologia
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Fabio H Rossi, Instituto Dante Pazzanese de Cardiologia
- Investigators
- Fabio H Rossi, PHD, Principal investigator, Instituto Dante Pazzanese de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149212
- Sponsor's protocol ID
- IDPC_2 2014
- Status last verified
- Jul 2014
- First submitted
- 25 May 2014
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alhalbouni 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 22018502Kolbel T, Lindh M, Akesson M, Wasselius J, Gottsater A, Ivancev K. Chronic iliac vein occlusion: midterm results of endovascular recanalization. J Endovasc Ther. 2009 Aug;16(4):483-91. doi: 10.1583/09-2719.1.
PubMed 19702343Raju 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 23433816Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.
PubMed 39968829Lorencao de Almeida B, Rossi FH, Guerra de Moraes Rego Sousa A, Kambara AM, Izukawa NM, Beteli CB, Andrade Cavalcante SF, Rodrigues TO, Thorpe PE. Correlation between venous pressure gradients and intravascular ultrasound in the diagnosis of iliac vein compression syndrome. J Vasc Surg Venous Lymphat Disord. 2018 Jul;6(4):492-499. doi: 10.1016/j.jvsv.2017.11.015. Epub 2018 Mar 8.
PubMed 29526687Rossi FH, Kambara AM, Izukawa NM, Rodrigues TO, Rossi CB, Sousa AG, Metzger PB, Thorpe PE. Randomized double-blinded study comparing medical treatment versus iliac vein stenting in chronic venous disease. J Vasc Surg Venous Lymphat Disord. 2018 Mar;6(2):183-191. doi: 10.1016/j.jvsv.2017.11.003. Epub 2017 Dec 29.
PubMed 29292114
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Trial Between Clinical and Endovascular Treatment in Patients With Advanced Chronic Venous Insufficiency and Iliac Venous Obstruction
- ClinicalTrials.gov ID
- NCT02149212
- Acronym / sponsor ID
- IDPC_2 2014
- Keywords
- Iliac, Vein, Stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Instituto Dante Pazzanese de CardiologiaUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 29 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.
About 90 % of vascular symptoms affecting the lower limbs consist of venous diseases. Its highest incidence occurs from the second decade of life, affecting significantly the economically active population. Chronic Venous Insufficiency treatment aims to relieve symptoms, treat and prevent complications, prevent recurrences and provide cosmetic satisfaction with minimal side effects. It's current treatment includes some classic postural measures (leg elevation), elastic stockings and bandages compression therapy and possible medication (phlebotonics). The results in the medium and long term are unfavorable, since a large number of patients do not get better or evolves with recurrence of symptoms. Nowadays many, no prospective , not randomized , international studies have shown favorable results with endovascular treatment of obstruction in the iliac vein territory in patients with advanced Chronic Venous Insufficiency . The purpose of this prospective, double-blinded randomized study is to evaluate the results obtained with endovascular treatment, through the use of angioplasty and stenting in this group of patients when compared with clinical treatment .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Treatment | Active comparator | Drug: Phlebotonic, Procedure: Limb elastic compression support, Procedure: Unna boot dressingPhlebotonics: Aminaftone 75 mg BID Limb elastic compression support (Elastic stockings: Venosan / Elastic Bandages: Atamed) Unna boot dressing |
| Iliac vein stenting | Active comparator | Drug: Phlebotonic, Device: Stent, Procedure: Limb elastic compression support, Procedure: Unna boot dressingWallstent |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 (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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhlebotonicAlso: AminaftoneAminaftone -- 75 mg BID | Drug | Clinical Treatment, Iliac vein stenting |
| StentAlso: WallstentIliac Vein Stenting | Device | Iliac vein stenting |
| Limb elastic compression supportAlso: Venosan compression stockings, Atamed elastic bandagesCEAP 3-5 > 20-30 mmHg compression stockings CEAP 6 > elastic bandages | Procedure or surgery | Clinical Treatment, Iliac vein stenting |
| Unna boot dressingCEAP 6 > Unna boot dressing | Procedure or surgery | Clinical Treatment, Iliac vein stenting |
Primary outcome
Change from baseline in pain on the Pain Visual Analogue Sacale at 6 months
Time frame: 6 months
Venous ulcer cicatrization at 6 months
Time frame: 6 months
5 secondary outcomes
Change from the baseline Venous Clinical Severity Score at 6 month
Time frame: 6 months
Change from baseline in SF-36 Quality of Life questionnaire at 6 months
Time frame: 6 months
Stent integrity at 6 months
Time frame: 6 months
Stent position at 6 months
Time frame: 6 months
Stent patency at 6 months
Time frame: 6 months
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 23 Jul 2014.
- 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 19702343Kolbel T, Lindh M, Akesson M, Wasselius J, Gottsater A, Ivancev K. Chronic iliac vein occlusion: midterm results of endovascular recanalization. J Endovasc Ther. 2009 Aug;16(4):483-91. doi: 10.1583/09-2719.1.
- 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.
- Derived from this study: PubMed 39968829Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.
- Derived from this study: PubMed 29526687Lorencao de Almeida B, Rossi FH, Guerra de Moraes Rego Sousa A, Kambara AM, Izukawa NM, Beteli CB, Andrade Cavalcante SF, Rodrigues TO, Thorpe PE. Correlation between venous pressure gradients and intravascular ultrasound in the diagnosis of iliac vein compression syndrome. J Vasc Surg Venous Lymphat Disord. 2018 Jul;6(4):492-499. doi: 10.1016/j.jvsv.2017.11.015. Epub 2018 Mar 8.
- Derived from this study: PubMed 29292114Rossi FH, Kambara AM, Izukawa NM, Rodrigues TO, Rossi CB, Sousa AG, Metzger PB, Thorpe PE. Randomized double-blinded study comparing medical treatment versus iliac vein stenting in chronic venous disease. J Vasc Surg Venous Lymphat Disord. 2018 Mar;6(2):183-191. doi: 10.1016/j.jvsv.2017.11.003. Epub 2017 Dec 29.
Related trials for Iliac Vein Obstruction
Active, not recruiting
Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)
Deep Vein Thrombosis, Venous Stasis
Recruiting
Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting
Deep Vein Thrombosis, Iliac Vein Thrombosis
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.
Fabio H Rossi, PHD principal investigator
Instituto Dante Pazzanese de Cardiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phlebotonic, Stent and Limb elastic compression support in people with Iliac Vein Obstruction and May-Thurner Syndrome, run by Instituto Dante Pazzanese de Cardiologia 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 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 23 Jul 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline in pain on the Pain Visual Analogue Sacale at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02149212, which also lists 6 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 23 Jul 2014.