RCT Comparing Standard Cannula Delivered FS, UGFS and ClariVein® in the Management of SVI (EVCA)
Superficial Venous Insufficiency, Varicose Veins
About this trial
This is an interventional treatment trial for Superficial Venous Insufficiency, Varicose Veins focused on measuring Superficial Venous Insufficiency
Eligibility Criteria
Inclusion Criteria:
• Aged 18 or over
- Symptomatic superficial venous insufficiency; Clinical grades C2 - C6; which will likely benefit from treatment in the opinion of an experienced specialist and the participant
- Superficial axial incompetence with proposed treatment lengths of >10cm. This axis may be a great saphenous vein (GSV), anterior accessory saphenous vein (ASV), small saphenous vein (SSV) or Giacomini vein (GV). Multiple veins can be treated.
- The proposed treatment length is straight enough to be cannulated with the catheter devices and the SVI is suitable for treatment with any modality in the study in the view of an experienced specialist
- Willing to participate (including acceptance of randomisation to either treatment) and give valid, informed consent
Exclusion Criteria:
• Inability to give informed written consent
- Unsuitable for any of the treatments in the opinion of a suitably experienced specialist.
- Unwilling or inability to comply with the requirements for follow-up visits.
- Known allergy to any of the key medications used in the treatment protocols
- Known right to left circulatory shunt
- Evidence of deep venous thrombosis or occlusion
- Active or recent thrombophlebitis (within 6 weeks)
- Impalpable foot pulses and an Ankle-Brachial Pressure Index of less than 0.8
- Pregnancy
- Active malignancy
- Immobility
Sites / Locations
- Hull Royal Infirmary
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Foam Sclerotherapy Group
Catheter Directed Foam Sclerotherapy (CDS) Group
ClariVein Group (CV) Treatment
The axial vein will be cannulated under local anaesthesia and ultrasound guidance with the patient reclined in a supine position for GSV or ASV treatment, prone position if SSV or GV treatment. The foam is then prepared by the Tessari technique by the surgeon. Two 2-ml syringes will be connected via a three way stop-cock tap and a 5 micron filter in series (Braun Medical, Sheffield, UK). The syringes will contain 1 part Sodium Tetradecyl Sulphate 3% and 3 parts air. In practice 0.5ml of 3% STS will be drawn up against 2 ml of air. The foam will be produced by at least 20 passages from syringe to syringe through the filter. Up to 2ml of foam will be injected into each cannula under ultrasound control to observe venous spasm, followed by gentle massaging of the skin to propagate the foam through the segment of vein treated.
The straight segment of axial vein will be cannulated under local anaesthesia at the lowest point of demonstrable reflux and a guide-wire inserted to facilitate the placement of the catheter system.The appropriate Unifuse® catheter will be selected and deployed through the introducer sheath and advanced to within 2cm of the junction or perforator at the upper limit of incompetence or the top of the incompetent segment in the case of segmental reflux. A 1:3 foam of 3% STD will be produced as described for FS. At this point the patient will be repositioned into a Trendelenburg position (head up)
The straight segment of axial vein will be cannulated under local anaesthesia at the lowest point of demonstrable reflux and the ClariVein device 4-F micro sheath will be introduced up the vein via a guide wire as per manufacturer's instructions. Concentration of STD will depend on axial vein to be treated; if treating GSV or ASV 1.5% STD liquid will be used, if SSV or GV 1.0% STD liquid will be used. Volume of STD to be prepared for the CV treatment will be calculated using a dosage chart provided by the manufacturer