RCT Comparing Standard Cannula Delivered FS, UGFS and ClariVein® in the Management of SVI (EVCA)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by University of Hull
Sponsor:
Information provided by (Responsible Party):
Daniel Carradice, University of Hull
ClinicalTrials.gov Identifier:
NCT02010437
First received: December 9, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

Leaking valves in the veins of the legs causes veins to become large and bloated. These swollen veins are called "varicose veins" and are a very common problem, affecting more than a third of all adults in the UK. Varicose veins reduce people's quality of life by causing problems such as pain, itching and restless legs. Varicose veins may also damage the skin over time causing problems such as bleeding, skin colour changes, eczema and even break-down in the skin which is called an ulcer. Newer, "key-hole" methods of treating leaky veins have been developed as an alternative to surgery and can be performed under local anaesthetic with the patient awake. Rather than cuts in the skin, these minimally invasive techniques are performed through tiny stab wounds; little larger than needle holes. The varicose vein is then destroyed from within, usually using heat to burn the inside of the vein. These procedures are popular; with a rapid recovery and a very high success rate. However these methods also require the vein to be surrounded by a large volume of dilute local anaesthetic which can to be slightly painful to administer. A technique called "Foam sclerotherapy" involves the injection of a drug which has been mixed into a foam. This goes into the vein and causes it to stick shut. This procedure is near painless to perform as very few, small local anaesthetic injections are required; however the chance for a successful treatment first time are lower and patients may need to return for repeat treatments to successfully treat the vein.

The aim of this study is to see whether the success rates for this technique can be improved. One method "catheter directed foam sclerotherapy" involves the delivery of the foam through a catheter (a long very thin tube), so that large lengths of vein can be treated through a single hole. The final method "ClariVein" again uses a catheter; but this time the catheter has a small wire on the end which spins around inside the vein; similar to an edge strimmer in the garden; except it irritates the vein: rather than cutting it. This irritation makes the vein more susceptible to the drug which can again be applied directly to the vein wall whilst it is still active. Early results show that this final method is very successful; however the equipment is more expensive than for the other two.

This study will randomly allocate willing participants with varicose veins to receive one of these three treatments to see whether the two newer treatments can improve the success rates and quality of life improvements seen with foam sclerotherapy, whilst also allowing near painless treatment, without significant complications, at an appropriate cost.


Condition Intervention Phase
Superficial Venous Insufficiency, Varicose Veins
Drug: Sodium Tetradecyl Sulphate (STS)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Clinical Trial Comparing Standard Cannula Delivered Foam Sclerotherapy, Catheter Directed Foam Sclerotherapy and ClariVein® Mechanochemical Ablation in the Management of Superficial Venous Insufficiency.

Resource links provided by NLM:


Further study details as provided by University of Hull:

Primary Outcome Measures:
  • technical success rate of treatment at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    The primary outcome of this trial is the technical success rate of treatment at 1 year. The ultrasound appearances of the axial vein will be categorised as:

    • Fully occluded
    • Partial recanalisation (≤15% by length)
    • Widespread recanalisation (>15% by length).


Secondary Outcome Measures:
  • Disease Specific Quality of Life (Aberdeen Varicose Vein Questionnaire AVVQ) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    The Aberdeen Varicose Vein Questionnaire (AVVQ) is a disease specific Quality of Life questionnaire which measures the QoL impairment associated with venous disease42. It is one of the most widely used venous disease specific QoL measurements and has been extensively validated43. The AVVQ consists 14 multiple choice questions and an unmarked diagram of the front and rear aspects of a pair of legs. The subject is invited to draw the distribution of their varicose veins on this diagram and the assessor uses a standardised acetate overlay with a grid pattern to score the number of affected segments. The AVVQ result has the added benefit over generic questionnaires in that it is more sensitive to small but significant differences in the health state of people with venous disease


Estimated Enrollment: 240
Study Start Date: January 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Foam Sclerotherapy Group

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.

Drug: Sodium Tetradecyl Sulphate (STS)
Other Name: Fibrovein
Active Comparator: Catheter Directed Foam Sclerotherapy (CDS) Group
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)
Drug: Sodium Tetradecyl Sulphate (STS)
Other Name: Fibrovein
Active Comparator: ClariVein Group (CV) Treatment
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
Drug: Sodium Tetradecyl Sulphate (STS)
Other Name: Fibrovein

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02010437

Locations
United Kingdom
Hull Royal Infirmary Not yet recruiting
Hull, United Kingdom, HU3 2JZ
Contact: Daniel Carradice, MBBS         
Principal Investigator: Ian C Chetter, MBChB         
Sponsors and Collaborators
University of Hull
  More Information

No publications provided

Responsible Party: Daniel Carradice, Academic Research Fellow, University of Hull
ClinicalTrials.gov Identifier: NCT02010437     History of Changes
Other Study ID Numbers: EVCA Trial
Study First Received: December 9, 2013
Last Updated: December 9, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Hull:
Superficial Venous Insufficiency

Additional relevant MeSH terms:
Varicose Veins
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases
Sodium Tetradecyl Sulfate
Sclerosing Solutions
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on October 19, 2014