Skip to main content
OpenTrials
Completed

NCT Number: NCT02454452

Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency

Randomized controlled clinical trial aimed to compare the effectiveness and safety of radiofrequency, saphenous vein stripping and conservative hemodynamic treatment of venous insufficiency (CHIVA) in the treatment of saphenous varicose veins, in terms of absence of saphenous vein reflux, patient quality of life and post-surgical complications.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Sabadell

Sabadell, Barcelona, 08208, Spain

About this study

A randomized controlled trial will compare three surgical techniques (stripping, CHIVA and radiofrequency) for the treatment of varicose veins which are currently considered interchangeable standards of care.

The trial will include symptomatic patients with chronic venous insufficiency and saphenous vein insufficiency confirmed by Doppler with diameter greater than 4 mm.

Clinical assessments will be made on first and seventh day after surgery, and then at months 1, 6, 12 and 24. The primary endpoint of the study is the absence of venous reflux in the great saphenous vein segment above-knee. Secondary variables will include VAS for pain and quality of life as assessed by the SF 36 and CIVIQ questionnaires validated in Spanish language. Ultrasound scans will be done the first week and after 1, 6, 12 and 24 months. Intra- and postoperative complications will be recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Insufficiency of internal major saphenous vein, confirmed by diameter greater than or equal to 4 mm, assessed by Eco- Dupplex.
  • Age > 18 years
  • Informed consent

Exclusion criteria

  • Recurrent varicose veins
  • Post-thrombotic syndrome.
  • Patients with active malignancies or severe ischemic heart disease.
  • Serious liver disease
  • Thrombophilia.
  • Serious psychiatric diseases

Treatment and study plan

Radiofrequency

Procedure

Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter

Saphenous vein stripping

Procedure

Saphenous vein stripping

CHIVA

Procedure

conservative hemodynamic treatment venous insufficiency

Primary outcomes

  1. Absence of venous reflux

    Time frame: 2 years

    Absence of venous reflux by duplex ultrasound

Secondary outcomes

  1. CIVIQ

    Time frame: 2 years

    Venous quality of Life questionnaire - Spanish validated version

  2. SF-36

    Time frame: 2 years

  3. VCSS

    Time frame: 2 years

    Venous Clinical Severity Score

  4. Surgical complications

    Time frame: 1 month

    Hematoma, echymosis, infection, bleeding, induration, neuritic pain

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

Comparative Randomized Clinical Study to Evaluate the Efficacy of Radiofrequency vs Surgical Technique of Internal Saphenous Vein Stripping and CHIVA Technique in the Treatment of Chronic Venous Insufficiency.

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
May 27, 2015
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.