Iliac Vein Stenting in Advanced Chronic Venous Insufficiency

NCT02149212 | Completed Phase 4 DMC

• 1 other identifier: IDPC_2 2014
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 .

Conditions

Iliac Vein Obstruction; May-Thurner Syndrome; Cockett Syndrome

Keywords

Iliac; Vein; Stent

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

  6 months

• Stent patency at 6 months

  6 months

Study Arms (2)

Clinical Treatment

ACTIVE COMPARATOR

Phlebotonics: Aminaftone 75 mg BID Limb elastic compression support (Elastic stockings: Venosan / Elastic Bandages: Atamed) Unna boot dressing

Drug: Phlebotonic; Procedure: Limb elastic compression support; Procedure: Unna boot dressing

Iliac vein stenting

ACTIVE COMPARATOR

Wallstent

Drug: Phlebotonic; Device: Stent; Procedure: Limb elastic compression support; Procedure: Unna boot dressing

Interventions

Phlebotonic DRUG

Aminaftone -- 75 mg BID

Also known as: Aminaftone

Clinical Treatment; Iliac vein stenting

Stent DEVICE

Iliac Vein Stenting

Also known as: Wallstent

Iliac vein stenting

Limb elastic compression support PROCEDURE

CEAP 3-5 \> 20-30 mmHg compression stockings CEAP 6 \> elastic bandages

Also known as: Venosan compression stockings, Atamed elastic bandages

Clinical Treatment; Iliac vein stenting

Unna boot dressing PROCEDURE

CEAP 6 \> Unna boot dressing

Clinical Treatment; Iliac vein stenting

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Dante Pazzanese de Cardiologia: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Instituto Dante Pazzanese de Cardilogia

São Paulo, São Paulo, 04012-909, Brazil

Location

Related Publications (6)

• 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.

  PMID: 22018502 BACKGROUND

• 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.

  PMID: 19702343 BACKGROUND

• 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.

  PMID: 23433816 BACKGROUND

• Flumignan 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.

  PMID: 39968829 DERIVED

• 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.

  PMID: 29526687 DERIVED

• 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.

  PMID: 29292114 DERIVED

MeSH Terms

Conditions

May-Thurner Syndrome

Interventions

aminaftone; Stents

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Peripheral Vascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Fabio H Rossi, PHD

  Instituto Dante Pazzanese de Cardiologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: May 25, 2014
• First Posted: May 29, 2014
• Study Start: February 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 23, 2014

Record last verified: 2014-07

Locations

BR (1)