Mechanochemical Ablation Compared to Cyanoacrylate Adhesive

Study Overview
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Brief Summary
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This study will be comparing the treatment of varicose veins using either mechanochemical ablation (MOCA) or cyanoacrylate adhesive (CAE). Patients will be randomised to receiving either MOCA or CAE. The pain scores, clinical scores, quality of life scores, occlusion and re-intervention rate at 2 weeks, 3, 6 and 12 months as well as the cost effectiveness of each intervention will be assessed.

Detailed Description
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This will be a randomised clinical trial comparing MOCA to CAE. Patients will be randomised into group A (MOCA) or group B (CAE). Only the endovenous ablation part of the procedure will be randomised while the decision as to whether patients should receive treatment of their varicose tributaries will be at the discretion of the clinical team. The device used for MOCA (group A) will be the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). The device used for CAE (group B) will be the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Re-intervention of the treated saphenous veins will not be decided until at least 3 months after their initial procedure.

Official Title
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Randomised Controlled Trial of Mechanochemical Ablation Versus Cyanoacrylate Adhesive for the Treatment of Varicose Veins

Conditions
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Varicose Veins

Intervention / Treatment
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* Procedure: Mechanochemical ablation
* Procedure: Cyanoacrylate adhesive


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults over 18 years of age Symptomatic GSV or SSV vein reflux > 0.5 seconds on colour Duplex Exclusion Criteria: Current DVT Recurrent varicose veins Arterial disease (ABPI<0.8) Vein diameter < 3mm Patient who are unwilling to participate Inability or unwillingness to complete questionnaires Adverse reaction to sclerosant or cyanoacrylate Not been involved in another venous trial for at least 6 months

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mechanochemical ablation (MOCA)<br>Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). | Procedure: Mechanochemical ablation<br>* Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)<br>|
| Active Comparator: Cyanoacrylate adhesive (CAE)<br>Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). | Procedure: Cyanoacrylate adhesive<br>* Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score During Ablation | Pain score during saphenous vein ablation using a 0-100mm visual analogue scale (0=no pain; 100=worst pain) | On day 0 immediately following vein ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score at the End of the Procedure | Pain score at the end of the procedure using a 0-100mm visual analogue scale (0=no pain; 100=worst pain) | On day 0 following vein ablation and any tributary treatment | 
| Generic Quality of Life as Per EQ-5D Questionnaire | Using the EuroQoL's EQ-5D questionnaire (-0.085=worse quality of life; 1.000=best quality of life) | Recorded at 12 months | 
| Disease Specific Quality of Life as Per the AVVQ | Using the Aberdeen Varicose Vein Questionnaire (AVVQ) questionnaire (0=best quality of life; 100=worse quality of life) | Recorded at 12 months | 
| Disease Specific Quality of Life as Per the CIVIQ-20 | Using the CIVIQ-20 questionnaire (0=best quality of life; 100=worse quality of life) | 12 months | 
| Clinical Change as Per VCSS | Using the Venous Clinical Severity Score (VCSS) (0=best; 30=worse) | 12 months | 
| Pain Score Over the First 10 Days | Pain score over the first 10 days using a 0-100mm visual analogue scale (0=no pain; 100=worst pain). The mean pain score was recorded daily and a mean value was calculated. | For the first 10 days since procedure | 
| Degree of Bruising at 2 Weeks | Degree of bruising at 2 weeks using a categorical 0-5 bruising scale (0=no bruising; 5=bruising extending beyond treated segment). The outcome measured is the number of participants with a degree of bruising between category 0-1. | 2 weeks | 
| Time to Return to Normal Activities | Length of time in days until normal activities are resumed | 2 weeks | 
| Occlusion Rates | Rate of occlusion as assessed by duplex ultrasound | 12 months |