MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins

Study Overview
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Brief Summary
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The newly developed Mechanochemical Endovenous Ablation (MOCA) device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. Heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. Previously we showed that endovenous MOCA, using polidocanol, is feasible and safe in the treatment of great spahenous vein (GSV) incompetence. However, larger studies with a prolonged follow-up to prove the efficacy of this technique in terms of obliteration rates are lacking. This randomized trial was designed to compare occlusion rate, post-operative pain and complications between radiofrequency ablation (RFA: the current treatment for GSV incompetence) en MOCA.

Official Title
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Mechanochemical Endovenous Ablation (MOCA) Versus RADiofrequeNcy Ablation (RFA) in the Treatment of Primary Great Saphenous Varicose Veins: a Multicentre Randomized Trial

Conditions
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Greater Saphenous Vein Injury

Intervention / Treatment
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* Device: Mechanochemical Endovenous Ablation (MOCA)
* Procedure: Radiofrequency ablation (RFA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Insufficiency of the GSV Signed informed consent Patient willing to participate in follow-up scheme Age > 18 years Ultrasound criteria for endovenous treatment have been met: Diameter GSV between 3-12 mm No thrombus in the to be treated segment of the GSV Exclusion Criteria: Patient not able to give informed consent Patient unable to present at follow-up visits Other treatment is more suitable Pregnancy and breast feeding Known allergy/ contra-indication for sclerotherapy Previous ipsilateral surgical treatment of varicose veins Deep venous thrombosis or lung emboli in medical history Anticoagulant therapy C5-C6 varices Immobilization Fontaine II or IV peripheral arterial disease Severe kidney function decline (GFS < 30 mL/min) Coagulation disorder or increased risk for thrombo-embolic complications(hemofilie A or B, v. Willebrand disease, Glanzmann disease, Factor VII-deficiency, idiopatic thrombocytopenic purpura, Factor V Leiden) Liver diseases accompanied by changes in blood coagulation, livver cirrhosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RFA<br>Radiofrequency Ablation (RFA) | Procedure: Radiofrequency ablation (RFA)<br>* Radiofrequency ablation (RFA)for treatment of great saphenous vein incompetence<br>* Other names: (RFA);|
| Experimental: MOCA<br>Mechanochemical Endovenous Ablation (MOCA) | Device: Mechanochemical Endovenous Ablation (MOCA)<br>* Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence<br>* Other names: (MOCA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion rate | Occlusion rates between treatments will be compared at mentioned time points (both technical and clinical success) | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Per-procedural pain score | Pain during the procedure will be compared between treatments using the VAS score | two weeks | 
| Complications | Complication at day 30 will be compared between treatments. | 30 days | 
| Procedure duration | The duration of the procedures will be compared | 30 days | 
| Costs of both treatments | The total costs of both treatments will be compared | 1 year | 
| Health status | Using the RAND 36-Item short From Health Survey (SF36) the general health status will be compared between treatments at various time points as specified by the protocol. | 1 year, 5 years | 
| Post procedural pain score | Pain during the the first two weeks after the procedure will be compared between treatments using the VAS score | two weeks | 
| Disease related quality of life | Using the Aberdeen Varicose Vein Questionnaire (AVVQ)the disease related quality of life will be compared between treatments at various time points as specified by the protocol. | 1 year, 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GSV, Primary Varicose Veins, Great Saphenous Vein, Treatment