Mechanochemical Ablation vs Thermal Ablation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Varicose Veins of Lower Limb

Intervention / Treatment
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* Procedure: MOCA
* Procedure: EVLA
* Procedure: RFA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Our study aim was to assess the applicability and safety of MOCA in short term as well as occlusion rate and disease specific quality of life one year after the procedure, and compare it with currently used thermal ablation methods of laser ablation (EVLA) and radiofrequency ablation (RFA) in a randomized controlled trial. Randomization took place by a study nurse after the appointment, using block randomization with sealed envelopes into EVLA, RFA, or MOCA in ratio 1:1:2.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MOCA<br>The refluxing GSV was treated with ClariVein catheter (endovenous mechanochemical ablation). | Procedure: MOCA<br>* Great saphenous vein occlusion with a mechanochemical chateter which cause mechanical injury to vessel intima and gives sclerosant to the intima.<br>|
| Active Comparator: EVLA<br>The refluxing GSV was treated with endovenous laser ablation. | Procedure: EVLA<br>* Great saphenous vein occlusion with a thermal laser chateter<br>|
| Active Comparator: RFA<br>The refluxing GSV was treated with radiofrequency ablation. | Procedure: RFA<br>* Great saphenous vein occlusion with a thermal radiofrequency chateter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion rate | Occlusion rate of the great saphenous vein | One year after the treatment | 
| Freedom from reflux | The absence of reflux in the treated great saphenous vein | One year after the treatment | 
| Disease-specific quality of life | Quality of life as measured by the Aberdeen Varicose Veins Questionnaire | One year after the treatment | 
| Occlusion rate | Occlusion rate of the great saphenous vein | three years after the treatment | 
| Freedom from reflux | The absence of reflux in the treated great saphenous vein | three years after the treatment | 
| Disease-specific quality of life | Quality of life as measured by the Aberdeen Varicose Veins Questionnaire | three years after the treatment | 
| Occlusion rate | Occlusion rate of the great saphenous vein | five years after the treatment | 
| Freedom from reflux | The absence of reflux in the treated great saphenous vein | five years after the treatment | 
| Disease-specific quality of life | Quality of life as measured by the Aberdeen Varicose Veins Questionnaire | five years after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peroperative and immediate postoperative pain | 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) | During the procedure, immediately after, and at one week after the treatment | 
| Sick leave | Number of sick leave days necessary after the treatment | During the immediate postoperative period up to one month | 
| Pain medication | The amount and type of pain medication received during and after the treatment | During the immediate postoperative period up to one month | 
| 30-day occlusion rate | The occlusion rate of the treated great saphenous vein | 30 days after the treatment | 
| Complications | All complications (deep venous thrombosis, nerve injuries, infections etc) after the treatment | Up to five years after the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Great saphenous vein, Thermal ablation, Mechanochemical ablation, Randomized controlled trial