Mechanochemical Ablation Compared to Cyanoacrylate Adhesive

Imperial College London167 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

167

Conditions

Varicose Veins

Interventions

Mechanochemical ablationPROCEDURE

Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)

Cyanoacrylate adhesivePROCEDURE

Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Charing Cross Hospital, Imperial College London

London, United Kingdom

Outcomes

Primary Outcomes

Pain Score During Ablation

Pain score during saphenous vein ablation using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)

Time frame: On day 0 immediately following vein ablation

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 12 months

Clinical Change as Per VCSS

Using the Venous Clinical Severity Score (VCSS) (0=best; 30=worse)

Time frame: 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.

Time frame: For the first 10 days since procedure

Data from ClinicalTrials.gov

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