Mechanochemical Ablation Compared to Cyanoacrylate Adhesive

Not Applicable

Completed

• Conditions: Varicose Veins
• Interventions: Procedure: Cyanoacrylate adhesive; Procedure: Mechanochemical ablation

• Registration Number: NCT03392753
• Lead Sponsor: Imperial College London

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-11-06
• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-08
• Primary Completion: 2019-07-31
• Results First Submitted: 2021-09-23
• Results First Submitted QC: 2021-12-06
• Results First Posted: 2021-12-07
• Study Completion: 2021-12-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

• Adults over 18 years of age
• Symptomatic GSV or SSV vein reflux > 0.5 seconds on colour Duplex

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyanoacrylate adhesive (CAE)	Cyanoacrylate adhesive	Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA).
Mechanochemical ablation (MOCA)	Mechanochemical ablation	Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Degree of Bruising at 2 Weeks	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.
Pain Score at the End of the Procedure	On day 0 following vein ablation and any tributary treatment	Pain score at the end of the procedure using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)
Occlusion Rates	12 months	Rate of occlusion as assessed by duplex ultrasound
Disease Specific Quality of Life as Per the CIVIQ-20	12 months	Using the CIVIQ-20 questionnaire (0=best quality of life; 100=worse quality of life)
Clinical Change as Per VCSS	12 months	Using the Venous Clinical Severity Score (VCSS) (0=best; 30=worse)
Generic Quality of Life as Per EQ-5D Questionnaire	Recorded at 12 months	Using the EuroQoL's EQ-5D questionnaire (-0.085=worse quality of life; 1.000=best quality of life)
Disease Specific Quality of Life as Per the AVVQ	Recorded at 12 months	Using the Aberdeen Varicose Vein Questionnaire (AVVQ) questionnaire (0=best quality of life; 100=worse quality of life)
Pain Score Over the First 10 Days	For the first 10 days since procedure	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.
Time to Return to Normal Activities	2 weeks	Length of time in days until normal activities are resumed

Trial Locations

Locations (1)

Charing Cross Hospital, Imperial College London; 🇬🇧 London, United Kingdom