Back to resultsIliac Vein Stenting in Advanced Chronic Venous Insufficiency
Primary Purpose
Iliac Vein Obstruction, May-Thurner Syndrome, Cockett Syndrome
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Phlebotonic
Stent
Limb elastic compression support
Unna boot dressing
Sponsored by
About this trial
This is an interventional treatment trial for Iliac Vein Obstruction focused on measuring Iliac, Vein, Stent
Eligibility 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 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
- 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.
Sites / Locations
- Instituto Dante Pazzanese de Cardilogia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Clinical Treatment
Iliac vein stenting
Arm Description
Phlebotonics: Aminaftone 75 mg BID Limb elastic compression support (Elastic stockings: Venosan / Elastic Bandages: Atamed) Unna boot dressing
Wallstent
Outcomes
Primary Outcome Measures
Change from baseline in pain on the Pain Visual Analogue Sacale at 6 months
Venous ulcer cicatrization at 6 months
Secondary Outcome Measures
Change from the baseline Venous Clinical Severity Score at 6 month
Change from baseline in SF-36 Quality of Life questionnaire at 6 months
Stent integrity at 6 months
Stent position at 6 months
Pelvic X-ray
Stent patency at 6 months
Stent patency obtained with treated venous segment Duplex Scanning
Full Information
NCT ID
NCT02149212
First Posted
May 25, 2014
Last Updated
July 22, 2014
Sponsor
Instituto Dante Pazzanese de Cardiologia
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02149212
Brief Title
Iliac Vein Stenting in Advanced Chronic Venous Insufficiency
Official Title
Randomized Double-blind Trial Between Clinical and Endovascular Treatment in Patients With Advanced Chronic Venous Insufficiency and Iliac Venous Obstruction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Dante Pazzanese de Cardiologia
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iliac Vein Obstruction, May-Thurner Syndrome, Cockett Syndrome
Keywords
Iliac, Vein, Stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinical Treatment
Arm Type
Active Comparator
Arm Description
Phlebotonics: Aminaftone 75 mg BID Limb elastic compression support (Elastic stockings: Venosan / Elastic Bandages: Atamed) Unna boot dressing
Arm Title
Iliac vein stenting
Arm Type
Active Comparator
Arm Description
Wallstent
Intervention Type
Drug
Intervention Name(s)
Phlebotonic
Other Intervention Name(s)
Aminaftone
Intervention Description
Aminaftone -- 75 mg BID
Intervention Type
Device
Intervention Name(s)
Stent
Other Intervention Name(s)
Wallstent
Intervention Description
Iliac Vein Stenting
Intervention Type
Procedure
Intervention Name(s)
Limb elastic compression support
Other Intervention Name(s)
Venosan compression stockings, Atamed elastic bandages
Intervention Description
CEAP 3-5 > 20-30 mmHg compression stockings CEAP 6 > elastic bandages
Intervention Type
Procedure
Intervention Name(s)
Unna boot dressing
Intervention Description
CEAP 6 > Unna boot dressing
Primary Outcome Measure Information:
Title
Change from baseline in pain on the Pain Visual Analogue Sacale at 6 months
Time Frame
6 months
Title
Venous ulcer cicatrization at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from the baseline Venous Clinical Severity Score at 6 month
Time Frame
6 months
Title
Change from baseline in SF-36 Quality of Life questionnaire at 6 months
Time Frame
6 months
Title
Stent integrity at 6 months
Time Frame
6 months
Title
Stent position at 6 months
Description
Pelvic X-ray
Time Frame
6 months
Title
Stent patency at 6 months
Description
Stent patency obtained with treated venous segment Duplex Scanning
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio H Rossi, PHD
Organizational Affiliation
Instituto Dante Pazzanese de Cardiologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Dante Pazzanese de Cardilogia
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04012-909
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
22018502
Citation
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.
Results Reference
background
PubMed Identifier
19702343
Citation
Kolbel 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.
Results Reference
background
PubMed Identifier
23433816
Citation
Raju 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.
Results Reference
background
PubMed Identifier
29526687
Citation
Lorencao 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.
Results Reference
derived
PubMed Identifier
29292114
Citation
Rossi 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.
Results Reference
derived
Learn more about this trial
Iliac Vein Stenting in Advanced Chronic Venous Insufficiency
We'll reach out to this number within 24 hrs