Laser Ablation Versus Mechanochemical Ablation Trial

NCT02627846 | Completed Phase 4 DMC

• 1 other identifier: R1788
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Varicose Veins

Outcome Measures

Primary Outcomes (2)

• Intra-procedural Pain

  Patient is asked immediately after the procedure of their level of pain experienced during the intervention; measured on a standardised visual analogue scale (VAS).

  Up to end of intervention

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

  At 1 year

Secondary Outcomes (15)

• Aberdeen Varicose Vein Questionnaire (AVVQ)

  1 week, 6 weeks, 6 months, 1 year

• Chronic Venous disease quality of life Questionnaire (CIVIQ-20)

  1 week, 6 weeks, 6 months, 1 year

• VEnous INsufficiency Epidemiological and Economic Study to evaluate Quality of Life and Symptoms (VEINES-QOL/Sym)

  1 week, 6 weeks, 6 months, 1 year

• Short Form 36

  1 week, 6 weeks, 6 months, 1 year

• EuroQol (EQ5D)

  1 week, 6 weeks, 6 months, 1 year

Study Arms (2)

EndoVenous Laser Ablation

ACTIVE COMPARATOR

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.

Device: EVLA; Drug: Lidocaine with 1:200,000 epinephrine solution; Drug: Sodium Bicarbonate

MechanoChemical Ablation (ClariVein®)

ACTIVE COMPARATOR

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.

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

Interventions

EVLA DEVICE

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.

Also known as: Endovenous Laser Ablation

EndoVenous Laser Ablation

ClariVein® DEVICE

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.

Also known as: Mechanochemical Ablation

MechanoChemical Ablation (ClariVein®)

Lidocaine with 1:200,000 epinephrine solution DRUG

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.

Also known as: Lignocaine with 1:200,000 adrenaline solution

EndoVenous Laser Ablation; MechanoChemical Ablation (ClariVein®)

Sodium Bicarbonate DRUG

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.

EndoVenous Laser Ablation

Sodium Tetradecyl Sulphate DRUG

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.

Also known as: Fibrovein Solution for Injection

MechanoChemical Ablation (ClariVein®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Hull and East Yorkshire Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom

Location

Related Publications (2)

• Mohamed AH, Leung C, Wallace T, Smith G, Carradice D, Chetter I. A Randomized Controlled Trial of Endovenous Laser Ablation Versus Mechanochemical Ablation With ClariVein in the Management of Superficial Venous Incompetence (LAMA Trial). Ann Surg. 2021 Jun 1;273(6):e188-e195. doi: 10.1097/SLA.0000000000003749.

  PMID: 31977509 DERIVED

• Leung CC, Carradice D, Wallace T, Chetter IC. Endovenous laser ablation versus mechanochemical ablation with ClariVein((R)) in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomised controlled trial. Trials. 2016 Aug 24;17(1):421. doi: 10.1186/s13063-016-1548-1.

  PMID: 27552990 DERIVED

Related Links

• Abstract Link
• Abstract Link
• Abstract Link

MeSH Terms

Conditions

Varicose Veins

Interventions

Lidocaine; Sodium Bicarbonate; Sodium Tetradecyl Sulfate; Injections

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Fatty Alcohols; Alcohols; Alkanesulfonates; Alkanesulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Lipids; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ian Chetter, MBChB,MD,FRCS

  Hull University Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

• Abduraheem Mohamed, MBBS,BSc,MRCS

  Hull University Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

• Daniel Carradice, MBBS,MRCS,DipHE

  Hull University Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 11, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: September 4, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-08

Locations

GB (1)