Mechanochemical Ablation Compared to Cyanoacrylate Adhesive

Varicose Veins Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392753
• Other study ID #: 17/LO/1457
• Status: Completed
• Phase: N/A
• Start date: November 6, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2022
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: December 31, 2021
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Procedure:
• Mechanochemical ablation
Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)
• Cyanoacrylate adhesive
Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)

Locations

Country	Name	City	State
United Kingdom	Charing Cross Hospital, Imperial College London	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Singapore General Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Clinical Change as Per VCSS	Using the Venous Clinical Severity Score (VCSS) (0=best; 30=worse)	12 months
Secondary	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
Secondary	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
Secondary	Time to Return to Normal Activities	Length of time in days until normal activities are resumed	2 weeks
Secondary	Occlusion Rates	Rate of occlusion as assessed by duplex ultrasound	12 months