Varicose Veins
Conditions
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.
Interventions
PROCEDUREMechanochemical ablation
Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)
PROCEDURECyanoacrylate adhesive
Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)
Sponsors
Singapore General Hospital
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
An internet-based randomisation service will be used Outcome assessors will be blinded as to treatment offered
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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. |
| Time to Return to Normal Activities | 2 weeks | Length of time in days until normal activities are resumed |
| Occlusion Rates | 12 months | Rate of occlusion as assessed by duplex ultrasound |
| 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. |
Countries
United Kingdom
Participant flow
Recruitment details
Recruitment period: November 2017 and February 2020 Recruitment location: 1. Charing Cross Hospital (Imperial College Healthcare NHS Trust) in London, UK; 2. Singapore General Hospital; 3. Sengkang General Hospital (Singapore)
Pre-assignment details
167 patients recruited
Participants by arm
| Arm | Count |
|---|---|
| Mechanochemical Ablation (MOCA) Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA).
Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein) | 83 |
| Cyanoacrylate Adhesive (CAE) Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA).
Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM) | 84 |
| Total | 167 |
Baseline characteristics
| Characteristic | Cyanoacrylate Adhesive (CAE) | Total | Mechanochemical Ablation (MOCA) |
|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 15 | 56 years STANDARD_DEVIATION 15 | 57 years STANDARD_DEVIATION 16 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Singapore | 34 participants | 67 participants | 33 participants |
| Region of Enrollment United Kingdom | 50 participants | 100 participants | 50 participants |
| Sex: Female, Male Female | 46 Participants | 99 Participants | 53 Participants |
| Sex: Female, Male Male | 38 Participants | 68 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 83 | 0 / 84 |
| other Total, other adverse events | 0 / 83 | 2 / 84 |
| serious Total, serious adverse events | 0 / 83 | 0 / 84 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mechanochemical Ablation (MOCA) | Pain Score During Ablation | 24 Units on a scale |
| Cyanoacrylate Adhesive (CAE) | Pain Score During Ablation | 20 Units on a scale |
Secondary
Clinical Change as Per VCSS
Using the Venous Clinical Severity Score (VCSS) (0=best; 30=worse)
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mechanochemical Ablation (MOCA) | Clinical Change as Per VCSS | 2 score on a scale |
| Cyanoacrylate Adhesive (CAE) | Clinical Change as Per VCSS | 2 score on a scale |
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.
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mechanochemical Ablation (MOCA) | Degree of Bruising at 2 Weeks | 53 participants |
| Cyanoacrylate Adhesive (CAE) | Degree of Bruising at 2 Weeks | 59 participants |
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)
Time frame: Recorded at 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mechanochemical Ablation (MOCA) | Disease Specific Quality of Life as Per the AVVQ | 4 score on a scale |
| Cyanoacrylate Adhesive (CAE) | Disease Specific Quality of Life as Per the AVVQ | 5.9 score on a scale |
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)
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mechanochemical Ablation (MOCA) | Disease Specific Quality of Life as Per the CIVIQ-20 | 3.5 score on a scale |
| Cyanoacrylate Adhesive (CAE) | Disease Specific Quality of Life as Per the CIVIQ-20 | 7.1 score on a scale |
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)
Time frame: Recorded at 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mechanochemical Ablation (MOCA) | Generic Quality of Life as Per EQ-5D Questionnaire | 1 score on a scale |
| Cyanoacrylate Adhesive (CAE) | Generic Quality of Life as Per EQ-5D Questionnaire | 1 score on a scale |
Secondary
Occlusion Rates
Rate of occlusion as assessed by duplex ultrasound
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mechanochemical Ablation (MOCA) | Occlusion Rates | 29 Participants |
| Cyanoacrylate Adhesive (CAE) | Occlusion Rates | 31 Participants |
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)
Time frame: On day 0 following vein ablation and any tributary treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mechanochemical Ablation (MOCA) | Pain Score at the End of the Procedure | 8 Units on a scale |
| Cyanoacrylate Adhesive (CAE) | Pain Score at the End of the Procedure | 11 Units on a scale |
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.
Time frame: For the first 10 days since procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mechanochemical Ablation (MOCA) | Pain Score Over the First 10 Days | 10.5 Units on a scale |
| Cyanoacrylate Adhesive (CAE) | Pain Score Over the First 10 Days | 7 Units on a scale |
Secondary
Time to Return to Normal Activities
Length of time in days until normal activities are resumed
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mechanochemical Ablation (MOCA) | Time to Return to Normal Activities | 7 days |
| Cyanoacrylate Adhesive (CAE) | Time to Return to Normal Activities | 8.5 days |