Mechanochemical Ablation vs Thermal Ablation

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Varicose Veins of Lower Limb

Treatments: Procedure: EVLA; Procedure: MOCA; Procedure: RFA

Study type: Interventional

Funder types: Other

Identifiers

NCT03722134

Clarivein RCT

Details and patient eligibility

About

Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one year.Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one and three years.

Full description

During 2014-2015, all patients referred to our vascular surgery clinic by their general practitioners due to varicose veins were screened for GSV insufficiency. We invited all patients filling the inclusion criteria to participate in this study.

Included patients were randomized to receive either thermal ablation (laser ablation or radiofrequency ablation) or mechanochemical ablation with the Clarivein device to treat the refluxing GSV.

The patients filled the Aberdeen Varicose Veins Questionnaire (AVVQ) at the baseline. We recorded the preoperative diameter of the GSV, specifically the diameter at the most proximal 20 centimetres, and the mean overall diameter at the thigh.

During the procedure, before discharge, and a week after, the patients reported pain scores using Visual Analogue Scale (VAS) on a scale of 0 to 10. At the one-month follow-up visit, we recorded wound healing, haematomas or bruising, nerve injuries, and pigmentation. The status of the GSV was examined with duplex Doppler ultrasound. The patients were also asked to determine what would have been the optimal sick leave after the procedure.

At the one-year follow-up, nerve injuries, pigmentation, and clinical status were recorded, as well as the status of the GSV with duplex Doppler ultrasound. The patients also filled the AVVQ questionnaire.

Enrollment: 132 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical classification of venous disease C2-C4
• ultrasound-verified reflux in the GSV
• mean GSV diameter in the thigh between 5 and 12 millimetres
• informed consent.

Exclusion criteria

• body mass index (BMI) of over 40
• peripheral arterial disease
• lymphoedema
• pregnancy
• allergy to either the sclerosant or lidocaine
• severe general illness
• malignancy
• previous deep venous thrombosis
• previous varicose vein intervention in the same leg
• coagulation disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 3 patient groups

MOCA

Experimental group

Description:

The refluxing GSV was treated with ClariVein catheter (endovenous mechanochemical ablation).

Treatment:

Procedure: MOCA

EVLA

Active Comparator group

Description:

The refluxing GSV was treated with endovenous laser ablation.

Treatment:

Procedure: EVLA

RFA

Active Comparator group

Description:

The refluxing GSV was treated with radiofrequency ablation.

Treatment:

Procedure: RFA