Iliac Vein Stenting in Advanced Chronic Venous Insufficiency

May-Thurner Syndrome Clinical Trial

Official title:

Randomized Double-blind Trial Between Clinical and Endovascular Treatment in Patients With Advanced Chronic Venous Insufficiency and Iliac Venous Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149212
• Other study ID #: IDPC_2 2014
• Status: Completed
• Phase: Phase 4
• First received: May 25, 2014
• Last updated: July 22, 2014
• Start date: February 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Instituto Dante Pazzanese de Cardiologia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical 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. 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cockett Syndrome
• Iliac Vein Obstruction
• May-Thurner Syndrome
• Syndrome
• Venous Insufficiency

Intervention

Drug:
• Phlebotonic
Aminaftone -- 75 mg BID

Device:
• Stent
Iliac Vein Stenting

Procedure:
• Limb elastic compression support
CEAP 3-5 > 20-30 mmHg compression stockings CEAP 6 > elastic bandages
• Unna boot dressing
CEAP 6 > Unna boot dressing

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese de Cardilogia	São Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Dante Pazzanese de Cardiologia	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View Citation

Kölbel T, Lindh M, Akesson M, Wassèlius J, Gottsäter 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain on the Pain Visual Analogue Sacale at 6 months		6 months	No
Primary	Venous ulcer cicatrization at 6 months		6 months	No
Secondary	Change from the baseline Venous Clinical Severity Score at 6 month		6 months	No
Secondary	Change from baseline in SF-36 Quality of Life questionnaire at 6 months		6 months	No
Secondary	Stent integrity at 6 months		6 months	Yes
Secondary	Stent position at 6 months	Pelvic X-ray	6 months	Yes
Secondary	Stent patency at 6 months	Stent patency obtained with treated venous segment Duplex Scanning	6 months	No