Clinical trial

A Randomised Clinical Trial Comparing Endovenous Laser Ablation and Mechanochemical Ablation (ClariVein®) in the Management of Superficial Venous Insufficiency

Name

R1788

Description

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

Trial arms

Trial start

2015-06-01

Estimated PCD

2018-08-01

Trial end

2023-09-04

Status

Completed

Phase

Early phase I

Treatment

EVLA

1% Lidocaine with 1:200,000 epinephrine will be used for skin infiltration. The EVLA fibre is introduced into the vein using the Seldinger technique and its tip will be positioned under duplex ultrasound (DUS). Then tumescent anaesthetic, made of a solution of 100ml of 1% Lidocaine with 1:200,000 epinephrine in 900ml of 0.9% Sodium Chloride and buffered to pH 7.4 with 10ml of 8.4% Sodium Bicarbonate, will be infiltrated around the target axial vein under DUS using a spinal needle and a peristaltic pump. Following deployment of appropriate laser safety precautions, the laser energy will be delivered via the fibre. The wavelength used is 1470nm, with NeverTouch Gold-Tip fibre, at 10W power. This laser light energy is converted into heat inducing a permanent, non-thrombotic occlusion.

Arms:

EndoVenous Laser Ablation

Other names:

Endovenous Laser Ablation

ClariVein®

1% Lidocaine with 1:200,000 epinephrine will be used for skin infiltration. MOCA is performed by a device called ClariVein® (Vascular Insights, UK) 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. The sclerosant will be Sodium Tetradecyl Sulphate (STS), marketed as Fibrovein. Concentration of 1.5% Fibrovein will be used, and maximum of 12ml.

Arms:

MechanoChemical Ablation (ClariVein®)

Other names:

Mechanochemical Ablation

Lidocaine with 1:200,000 epinephrine solution

It is used as local anaesthetic given via subcutaneous injection, so that the skin is numb prior to the introduction of either endovenous laser ablation or mechenochemical ablation catheter. Typically 1-2ml is required.

Arms:

EndoVenous Laser Ablation, MechanoChemical Ablation (ClariVein®)

Other names:

Lignocaine with 1:200,000 adrenaline solution

Lidocaine with 1:200,000 epinephrine solution

100ml of 1% lidocaine with 1:200,000 epinephrine is diluted into 900ml of 0.9% Sodium Chloride to make the tumescent anaesthetic solution, which is required when using endovenous laser ablation.

Arms:

EndoVenous Laser Ablation

Other names:

Lignocaine with 1:200,000 adrenaline solution

Sodium Bicarbonate

10ml of 8.4% Sodium Bicarbonate is added into the tumescent anaesthetic solution, to buffer the pH to 7.4. Tumescent anaesthetic solution is required when using endovenous laser ablation.

Arms:

EndoVenous Laser Ablation

Sodium Tetradecyl Sulphate

1.5% of Sodium Tetradecyl Sulphate, marketed as Fibrovein, will be used with the mechanochemical ablation device (ClariVein®). This is a sclerosing agent with Manufacturer Authorisation, and it will be used unmodified. Intravenous injection causes intima inflammation and thrombus formation. This usually occludes the injected vein.

Arms:

MechanoChemical Ablation (ClariVein®)

Other names:

Fibrovein Solution for Injection

Size

150

Primary endpoint

Intra-procedural Pain

Up to end of intervention

Technical Efficacy assessed by successful procedure defined as complete occlusion of the target vein segment.

At 1 year

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ACTUAL'}}

Updated at

2023-09-21

1 organization

4 products

1 indication

Organization

Hull University Teaching Hospitals NHS Trust

Product

Lidocaine with Epinephrine

Indication

Varicose Veins

Product

Lidocaine with 1:200,000 epinephrine

Product

Sodium Bicarbonate

Product

Sodium Tetradecyl Sulphate