Skip to main content
OpenTrials
Completed

NCT Number: NCT03722134

Mechanochemical Ablation vs Thermal Ablation

Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one year.Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one and three years.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

During 2014-2015, all patients referred to our vascular surgery clinic by their general practitioners due to varicose veins were screened for GSV insufficiency. We invited all patients filling the inclusion criteria to participate in this study.

Included patients were randomized to receive either thermal ablation (laser ablation or radiofrequency ablation) or mechanochemical ablation with the Clarivein device to treat the refluxing GSV.

The patients filled the Aberdeen Varicose Veins Questionnaire (AVVQ) at the baseline. We recorded the preoperative diameter of the GSV, specifically the diameter at the most proximal 20 centimetres, and the mean overall diameter at the thigh.

During the procedure, before discharge, and a week after, the patients reported pain scores using Visual Analogue Scale (VAS) on a scale of 0 to 10. At the one-month follow-up visit, we recorded wound healing, haematomas or bruising, nerve injuries, and pigmentation. The status of the GSV was examined with duplex Doppler ultrasound. The patients were also asked to determine what would have been the optimal sick leave after the procedure.

At the one-year follow-up, nerve injuries, pigmentation, and clinical status were recorded, as well as the status of the GSV with duplex Doppler ultrasound. The patients also filled the AVVQ questionnaire.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • clinical classification of venous disease C2-C4
  • ultrasound-verified reflux in the GSV
  • mean GSV diameter in the thigh between 5 and 12 millimetres
  • informed consent.

Exclusion criteria

  • body mass index (BMI) of over 40
  • peripheral arterial disease
  • lymphoedema
  • pregnancy
  • allergy to either the sclerosant or lidocaine
  • severe general illness
  • malignancy
  • previous deep venous thrombosis
  • previous varicose vein intervention in the same leg
  • coagulation disorders

Treatment and study plan

MOCA

Procedure

Great saphenous vein occlusion with a mechanochemical chateter which cause mechanical injury to vessel intima and gives sclerosant to the intima.

EVLA

Procedure

Great saphenous vein occlusion with a thermal laser chateter

RFA

Procedure

Great saphenous vein occlusion with a thermal radiofrequency chateter

Primary outcomes

  1. Occlusion rate

    Time frame: One year after the treatment

    Occlusion rate of the great saphenous vein

  2. Freedom from reflux

    Time frame: One year after the treatment

    The absence of reflux in the treated great saphenous vein

  3. Disease-specific quality of life

    Time frame: One year after the treatment

    Quality of life as measured by the Aberdeen Varicose Veins Questionnaire

  4. Occlusion rate

    Time frame: three years after the treatment

    Occlusion rate of the great saphenous vein

  5. Freedom from reflux

    Time frame: three years after the treatment

    The absence of reflux in the treated great saphenous vein

  6. Disease-specific quality of life

    Time frame: three years after the treatment

    Quality of life as measured by the Aberdeen Varicose Veins Questionnaire

  7. Occlusion rate

    Time frame: five years after the treatment

    Occlusion rate of the great saphenous vein

  8. Freedom from reflux

    Time frame: five years after the treatment

    The absence of reflux in the treated great saphenous vein

  9. Disease-specific quality of life

    Time frame: five years after the treatment

    Quality of life as measured by the Aberdeen Varicose Veins Questionnaire

Secondary outcomes

  1. Peroperative and immediate postoperative pain

    Time frame: During the procedure, immediately after, and at one week after the treatment

    Perceived pain using Visual Analogue Scale (Range 0-10; 0=no pain; 2=Mild pain, 4=Nagging, uncomfortable pain; 6= Miserable pain; 8=Horrible pain; 10=worst possible, unbearable pain)

  2. Sick leave

    Time frame: During the immediate postoperative period up to one month

    Number of sick leave days necessary after the treatment

  3. Pain medication

    Time frame: During the immediate postoperative period up to one month

    The amount and type of pain medication received during and after the treatment

  4. 30-day occlusion rate

    Time frame: 30 days after the treatment

    The occlusion rate of the treated great saphenous vein

  5. Complications

    Time frame: Up to five years after the treatment

    All complications (deep venous thrombosis, nerve injuries, infections etc) after the treatment

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

Mechanochemical Ablation vs Thermal Ablation in Patients With Great Saphenous Vein Insufficiency

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Oct 26, 2018
Registry last updated
Feb 10, 2021

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.

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