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Iliac Vein Stenting in Advanced Chronic Venous Insufficiency

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ClinicalTrials.gov Identifier: NCT02149212
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : July 23, 2014
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Fabio H Rossi, Instituto Dante Pazzanese de Cardiologia

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 .

Condition or disease Intervention/treatment Phase
Iliac Vein Obstruction May-Thurner Syndrome Cockett Syndrome Drug: Phlebotonic Device: Stent Procedure: Limb elastic compression support Procedure: Unna boot dressing Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double-blind Trial Between Clinical and Endovascular Treatment in Patients With Advanced Chronic Venous Insufficiency and Iliac Venous Obstruction
Study Start Date : February 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Aminaftone

Device: Stent
Iliac Vein Stenting
Other Name: Wallstent

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




Primary Outcome Measures :
  1. Change from baseline in pain on the Pain Visual Analogue Sacale at 6 months [ Time Frame: 6 months ]
  2. Venous ulcer cicatrization at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change from the baseline Venous Clinical Severity Score at 6 month [ Time Frame: 6 months ]
  2. Change from baseline in SF-36 Quality of Life questionnaire at 6 months [ Time Frame: 6 months ]
  3. Stent integrity at 6 months [ Time Frame: 6 months ]
  4. Stent position at 6 months [ Time Frame: 6 months ]
    Pelvic X-ray

  5. Stent patency at 6 months [ Time Frame: 6 months ]
    Stent patency obtained with treated venous segment Duplex Scanning



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149212


Locations
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Brazil
Instituto Dante Pazzanese de Cardilogia
São Paulo, Sao Paulo, Brazil, 04012-909
Sponsors and Collaborators
Instituto Dante Pazzanese de Cardiologia
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Fabio H Rossi, PHD Instituto Dante Pazzanese de Cardiologia

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fabio H Rossi, PHD, Instituto Dante Pazzanese de Cardiologia
ClinicalTrials.gov Identifier: NCT02149212     History of Changes
Other Study ID Numbers: IDPC_2 2014
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: July 2014

Keywords provided by Fabio H Rossi, Instituto Dante Pazzanese de Cardiologia:
Iliac
Vein
Stent

Additional relevant MeSH terms:
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Syndrome
Venous Insufficiency
May-Thurner Syndrome
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Vascular Malformations
Cardiovascular Abnormalities
Peripheral Vascular Diseases
Congenital Abnormalities
Aminaftone
Hemostatics
Coagulants