Condition category
Circulatory System
Date applied
22/07/2012
Date assigned
16/08/2012
Last edited
04/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Varicose veins are a common problem and affect about 30-40% of the population at some point in their lives. The severity of varicose veins varies from purely cosmetic to severe leg ulceration and it has been shown that treating varicose veins results in significant improvements in quality of life. New minimally invasive treatments have become available in the last decade - these are termed endovenous ablation treatments (inside-the-vein closure treatments). These techniques either use energy to heat the inside of the vein, causing it to stick together and block off (ablation). Alternatively, we can use chemicals (glues) to stick the vein together (pharmacological occlusion) or a combination of a mechanical tip and chemicals to stick the vein together and block it off (pharmaco-mechanical ablation). All of these treatments seal off the problem vein. In this trial we are using either radiofrequency heat ablation or pharmaco-mechanical ablation to seal off the vein. Endovenous radiofrequency ablation treatment uses heat energy delivered via a probe inserted into the vein in order to treat the long veins in the leg, and has been shown to be safe and effective. The device is called VNUS ClosureFAST. Pharmacomechanical ablation treatment uses a rotating metal tip to 'scratch' the lining of the vein and inject a liquid chemical called sclerosant into the vein at the same time. The sclerosant causes the vein to stick together. This technique has also been shown to be safe and effective. The device is called ClariVein. The varicosities (or lumpy veins) are removed via small cuts (<0.5 cm long) in the skin termed 'phlebectomies' or 'avulsions', performed at the same time as the long veins are treated. Foam sclerotherapy can be used as an alternative to avulsions. This uses a special chemical made into foam, which is injected into the varicose veins using small needles. As with liquid sclerosant it causes the vein to stick together and block off (sclerose).

Who can participate?
Any male or female over the age of 18, with symptomatic varicose veins (long or short saphenous veins).

What does the study involve?
We will ask you about your medical history and fill in a questionnaire with you. You will be assigned a trial number and your treatment plan will be randomly allocated. The allocation will not affect the standard of your care. It will decide the treatment device used. Both are standard care treatment options. You will then have endovenous treatment of your varicose veins with avulsions. The treatment will use either VNUS radiofrequency thermal ablation (heat treatment) or ClariVein pharmacomechanical ablation (mechanical and chemical treatment). This will be carried out under local anaesthetic. You will be asked to score the level of pain experienced during the procedure using a special scale. You will then be asked to keep a patient diary for the 30 days after treatment. 30 days after your treatment you will be reviewed in clinic with a further questionnaire and a repeat venous duplex. Six months after your operation you will again be reviewed in clinic with a venous duplex ultrasound of your leg to assess technical success and another questionnaire.

What are the possible benefits and risks of participating?
You are not expected to gain any personal benefit from taking part in this study. However, the information gained may help other people in the future. It is not possible to offer any financial incentive for taking part in the study. There are no specific side-effects, disadvantages or risks from taking part in this study as both treatments offered are standard practice. The differing techniques are utilised throughout the world. The specific risks of varicose vein treatment are the same for all treatments - the most common are bleeding, bruising and infection. This is because cuts are made in the skin and the veins, which would be expected to lead to some bleeding, which is controlled at the operation. Cuts in the skin provide a possible route of entry for infection, which is controlled with antibiotics at the operation and further antibiotics if required. The major complication associated with all varicose vein procedures is a deep vein thrombosis (DVT). This is a clot in the deep veins of the leg (famously called ‘economy class syndrome’). This is reduced in the case of endovenous treatment due to reduced to pain post-operatively - patients are often back at work the day after the procedure. Due to the minimally-invasive ('keyhole') technique the risk of serious bleeding is greatly reduced in endovenous treatment and we are able to give a special blood-thinning injection to help reduce the risk of clots in the leg veins.

Where is the study run from?
Imperial College Healthcare NHS Trust and Imperial College (UK).

When is the study starting and how long is it expected to run for?
The study started in August 2012 and is expected to end in September 2014. A one-page plain English summary of the study results will be available from the email address below in 2014.

Who is funding the study?
Vascular Insights (USA).

Who is the main contact?
Mr Tristan Lane
tristan.lane@imperial.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Alun Davies

ORCID ID

Contact details

Academic Section of Vascular Surgery
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
tristan.lane@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P40864

Study information

Scientific title

Randomised clinical trial comparing VNUS ClosureFAST with ClariVein for varicose veins

Acronym

VVCVV

Study hypothesis

ClariVein procedure for varicose veins is significantly less painful than radiofrequency ablation under local anaesthetic.

Updated 04/07/2014: This study is now in follow-up.

Ethics approval

1. London - Chelsea Research Ethics Committee, 21/05/2012, ref: 12/LO/0570
2. Joint Research Office, Imperial College London and Imperial College Healthcare NHS Trust, 03/07/2012, ref: JRC0HH0431

Study design

Randomised clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Varicose veins, venous disease

Intervention

Treatment arm one is:
VNUS ClosureFast radiofrequency ablation of the incompetent long or short saphenous vein with phlebectomies as per standard published treatment technique.

Treatment arm two is:
ClariVein mechanochemical ablation of the incompetent long or short saphenous vein with phlebectomies as per standard published treatment technique.
There is no medication utilised. The treatment if one sitting in an outpatient procedure.

Follow-up is 6 months in both arms.

Patients will be randomised to receive one of the possible treatment options. Treatments will be completed under local anaesthetic with concomitant phlebectomy if necessary. Randomisation will be via an internet randomisation service.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. A comparison of pain during the procedure measured using a patient-reported visual analogue score (VAS) comparing RFA and ClariVein®
2. Treatments will be performed under local anaesthetic with concomitant phlebectomy to treat varicosities
3. Pain during the procedure will be measured using a validated patient-reported Visual Analogue Score (VAS)

Secondary outcome measures

1. Quality of life at 30 days and 6 months measured using the Aberdeen Varicose Vein Severity Score (AVVSS)
2. Occlusion rates at 30 day and 6 months
3. Clinical success, including residual varicosities, complications and recurrence rates at 6 months
4. Improvements in generic quality of life using the EQ-5D at 30 days and 6 months
5. Clinical improvements measured using the Venous Clinical Severity Score (VCSS) at 30 days and 6 months
6. Time to return to work and normal activities assessed using a 30-day patient diary
7. A comparison of the cost-effectiveness of the treatment regimes will be made

Overall trial start date

31/08/2012

Overall trial end date

01/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults over 18 years of age
2. Symptomatic long or short saphenous vein reflux < 0.5 seconds on colour duplex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

170

Participant exclusion criteria

1. Current DVT
2. Recurrent varicose veins
3. Arterial disease (ABPI <0.8)
4. Veins less than 3 mm in diameter
5. Hypercoagulability
6. Patients who are unwilling to participate
7. Inability or unwillingness to complete questionnaires

Recruitment start date

31/08/2012

Recruitment end date

01/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Section of Vascular Surgery
London
W6 8RF
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

Joint Research Compliance Office
Imperial College London and Imperial College Healthcare NHS Trust
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor type

University/education

Website

http://www.imperial.ac.uk/clinicalresearchgovernanceoffice

Funders

Funder type

Industry

Funder name

Vascular Insights (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes