Iliac Vein Stenting in Advanced Chronic Venous Insufficiency

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 .

Study Overview

• Status: Completed
• Conditions: May-Thurner Syndrome; Iliac Vein Obstruction; Cockett Syndrome
• Intervention / Treatment: Drug: Phlebotonic; Procedure: Limb elastic compression support; Procedure: Unna boot dressing; Device: Stent

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 04012-909
      • Instituto Dante Pazzanese de Cardilogia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clinical Treatment; Phlebotonics: Aminaftone 75 mg BID Limb elastic compression support (Elastic stockings: Venosan / Elastic Bandages: Atamed) Unna boot dressing	Drug: Phlebotonic; Aminaftone -- 75 mg BID; Other Names: Aminaftone; Procedure: Limb elastic compression support; CEAP 3-5 > 20-30 mmHg compression stockings CEAP 6 > elastic bandages; Other Names: Venosan compression stockings; Atamed elastic bandages; Procedure: Unna boot dressing; CEAP 6 > Unna boot dressing
Active Comparator: Iliac vein stenting; Wallstent	Drug: Phlebotonic; Aminaftone -- 75 mg BID; Other Names: Aminaftone; Procedure: Limb elastic compression support; CEAP 3-5 > 20-30 mmHg compression stockings CEAP 6 > elastic bandages; Other Names: Venosan compression stockings; Atamed elastic bandages; Procedure: Unna boot dressing; CEAP 6 > Unna boot dressing; Device: Stent; Iliac Vein Stenting; Other Names: Wallstent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in pain on the Pain Visual Analogue Sacale at 6 months	6 months
Venous ulcer cicatrization at 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from the baseline Venous Clinical Severity Score at 6 month		6 months
Change from baseline in SF-36 Quality of Life questionnaire at 6 months		6 months
Stent integrity at 6 months		6 months
Stent position at 6 months	Pelvic X-ray	6 months
Stent patency at 6 months	Stent patency obtained with treated venous segment Duplex Scanning	6 months

Collaborators and Investigators

• Sponsor: Instituto Dante Pazzanese de Cardiologia
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Fabio H Rossi, PHD, Instituto Dante Pazzanese de Cardiologia

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: May 25, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): May 29, 2014

Study Record Updates

• Last Update Posted (Estimate): July 23, 2014
• Last Update Submitted That Met QC Criteria: July 22, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Stent; Vein; Iliac
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Peripheral Vascular Diseases; Syndrome; Venous Insufficiency; May-Thurner Syndrome; Hemostatics; Coagulants; Aminaftone
• Other Study ID Numbers: IDPC_2 2014