Delayed or Immediate Local Treatment of Veins (DELICATVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03340246
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : November 14, 2017
Information provided by (Responsible Party):
Maarit Venermo, Helsinki University Central Hospital

Brief Summary:

Varicose veins affect a majority of adult patients and cause a decreased quality of life. In recent years, standard practice has been to perform thermoablation and local phlebectomies in the same procedure. There is conflicting data on the long-term outcome of the local varicose veins; there seems to be a need for more re-interventions if the local varicosities are not treated immediately. On the other hand, the prolonged combined procedure increases procedural pain and bleeding, as well as the risk for complications from deep vein thrombosis/pulmonary embolism.

This trial aims to evaluate the need for immediate treatment of local varicosities and the potential sufficiency of main trunk treatment.

Condition or disease Intervention/treatment Phase
Varicose Veins Leg Procedure: Delayed sclerotherapy Procedure: Immediate phlebectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Delayed or Immediate Local Treatment of Varicose Veins
Actual Study Start Date : May 4, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arm Intervention/treatment
Active Comparator: Immediate phlebectomy
Mechanochemical ablation of main trunk and immediate phlebectomy of varicosities
Procedure: Immediate phlebectomy
See arm description

Experimental: Delayed treatment
Mechanochemical ablation of main trunk. Evaluation of varicosities at 3 months with sclerotherapy if required
Procedure: Delayed sclerotherapy
See arm descriptions

Primary Outcome Measures :
  1. Need for sclerotherapy [ Time Frame: 3 months ]
    Need for sclerotherapy of varicosities at three months after ablation of main trunk. Evaluated by the CEAP-classification of venous insufficiency. >C2 will be eligible for treatment.

Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 3 months ]
    Overall patient satisfaction and symptoms regarding varicosities and procedure at three months. Evaluated by the Aberdeen Varicose Veins Questionnaire (AVVQ). The AVVQ is a validated test, in which patients are asked to check boxes with regard to symptoms and quality of life (QoL). Scale 0-100, with 100 indicating worst possible QoL.

  2. Occlusion rate of great saphenous vein [ Time Frame: 36 months ]
    Long-term occlusion rate of main trunk after mechanochemical ablation, evaluated by duplex ultrasound.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ultrasound verified insufficiency of great saphenous vein (GSV)
  • GSV diameter 5-10 mm
  • C2-C4 varicosities
  • Most proximal insufficient branch in the distal thigh
  • Written and signed informed consent

Exclusion Criteria:

  • Peripheral arterial disease
  • Body mass index >40
  • Lymphoedema
  • Known allergy to sclerosant
  • Any known coagulopathy or history of deep vein thrombosis
  • Severe illness
  • Pregnancy

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 identifier (NCT number): NCT03340246

Contact: Karoliina Halmesmäki, M.D., Ph.D. +358405632794
Contact: Maarit Venermo, M.D., Ph.D. +358504272117

Helsinki University Hospital Recruiting
Helsinki, Finland, 00029
Contact: Maarit Venermo, Professor    +358504272117   
Contact: Karoliina Halmesmäki, M.D., Ph.D.   
Sub-Investigator: Sari Vähäaho, M.D.         
Sub-Investigator: Patrick Björkman, M.D.         
Sponsors and Collaborators
Helsinki University Central Hospital
Principal Investigator: Karoliina Halmesmäki, M.D., Ph.D Helsinki University Central Hospital
Study Director: Maarit Venermo, M.D., Ph.D. Helsinki University Central Hospital

Responsible Party: Maarit Venermo, Professor of Vascular Surgery, Helsinki University Central Hospital Identifier: NCT03340246     History of Changes
Other Study ID Numbers: DELICATVE
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maarit Venermo, Helsinki University Central Hospital:
Varicose veins, phlebectomy

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases