Laser Ablation Versus Mechanochemical Ablation Trial (LAMA)

NHS Trust

Status and phase: Completed; Phase 4

Conditions: Varicose Veins

Treatments: Device: EVLA; Device: ClariVein®; Drug: Lidocaine with 1:200,000 epinephrine solution; Drug: Sodium Bicarbonate; Drug: Sodium Tetradecyl Sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT02627846

R1788

Details and patient eligibility

About

A randomised clinical trial comparing endovenous laser ablation and mechanochemical ablation (ClariVein®) in the management of superficial venous insufficiency.

Full description

Varicose veins, a very common problem in UK, may cause symptoms including pain, heaviness and itching in the lower legs. Overtime, bleeding and damage to surround soft tissues may develop, leading to venous ulcer which can be very painful, debilitating, difficult to heal and very expensive to treat.

Newer minimally invasive techniques are preformed using local anaesthetic. The recovery has been shown to be more rapid, due to less pain and disability when compared to open surgery. These techniques use either heat or a chemical/medicine injected inside the varicose veins to close them permanently. In 2013 National Institute of Health and Care Excellence (NICE) recommended that methods using heat such as endovenous laser ablation (EVLA) should be first choice as the chemical methods have been shown to have a significantly lower treatment success rates in closing varicose veins permanently. Chemical methods however do have their advantages, as they require far fewer injections of local anaesthetic than the heat methods and these injections can be a source of significant discomfort.

Since NICE guidelines, a new treatment technique known as mechanochemical ablation (MOCA) using ClariVein® has been developed. This device injects a chemical into the vein through a rotating hollow wire, which causes the vein to narrow and damages the lining of the vein, making the chemical more effective. This new treatment technique aims to match the success rates of the heat method, but with less pain since it avoids most of the local anaesthetic injections. Both treatments are currently used in the UK, however there is insufficient evidence as to whether one is better, or the same.

This trial will randomly allocate volunteer patients to have their varicose veins treated with either EVLA or MOCA. The investigators will assess a range of outcomes including pain scores, success rates, complications, quality-of-life and costs to see which, if any, of these treatments offer better results. Long term follow-ups will occur at 5 and 10 years.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 or over
• Symptomatic SVI which will likely benefit from treatment in the opinion of an experienced specialist and the participant
• Clinical grades C2-C6 on the CEAP system
• Superficial axial incompetence with proposed treatment lengths of at least 10cm
• Treatment with either endovenous laser ablation or mechanochemical ablation is technically feasible in the view of an experienced endovenous specialist
• Patient is willing to participate (including acceptance of randomisation to either treatment) and give valid, informed consent in the English language

Exclusion criteria

• One of the treatments is thought to be preferable by either the patient or an experienced endovenous specialist
• Unwilling or inability to comply with the requirements for follow-up visits
• Known allergy to medications or dressings used in the treatment
• Known right to left circulatory shunt
• Evidence of acute deep venous thrombosis or complete ipsilateral occlusion
• Pelvic vein insufficiency
• Active or recent thrombophlebitis (within 6 weeks)
• Impalpable foot pulses with an Ankle-Brachial Pressure Index of less than 0.8
• Pregnancy or breast feeding
• Active malignancy
• Immobility
• Involvement in other CTIMP trials within the last 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

EndoVenous Laser Ablation

Active Comparator group

Description:

EndoVenous Laser Ablation (EVLA) involves the delivery of laser light through a glass fibre placed into the lumen of a refluxing vein. This energy is converted into heat inducing a permanent, non-thrombotic occlusion.

Treatment:

Drug: Sodium Bicarbonate

Drug: Lidocaine with 1:200,000 epinephrine solution

Drug: Lidocaine with 1:200,000 epinephrine solution

Device: EVLA

MechanoChemical Ablation (ClariVein®)

Active Comparator group

Description:

Mechanochemical ablation (MOCA) is performed by a device called ClariVein® which is a long thin catheter that is passed up inside the vein, with a rotating wire that protrudes at an angle from the end when deployed. This is motorised via an electric motor in the handle and rotates at approximately 3500 revolutions per minute. In addition, liquid sclerotherapy is injected at the handle end by a syringe. This sclerotherapy liquid emerges from the end of the catheter and is present in the area of the rotating tip.

Treatment:

Drug: Sodium Tetradecyl Sulphate

Drug: Lidocaine with 1:200,000 epinephrine solution

Device: ClariVein®

Drug: Lidocaine with 1:200,000 epinephrine solution