Mechanochemical Ablation vs Thermal Ablation

Mechanochemical Ablation vs Thermal Ablation in Patients With Great Saphenous Vein Insufficiency

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.

Study Overview

• Status: Completed
• Conditions: Varicose Veins of Lower Limb
• Intervention / Treatment: Procedure: MOCA; Procedure: EVLA; Procedure: RFA

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MOCA; The refluxing GSV was treated with ClariVein catheter (endovenous mechanochemical ablation).	Procedure: MOCA; Great saphenous vein occlusion with a mechanochemical chateter which cause mechanical injury to vessel intima and gives sclerosant to the intima.
Active Comparator: EVLA; The refluxing GSV was treated with endovenous laser ablation.	Procedure: EVLA; Great saphenous vein occlusion with a thermal laser chateter
Active Comparator: RFA; The refluxing GSV was treated with radiofrequency ablation.	Procedure: RFA; Great saphenous vein occlusion with a thermal radiofrequency chateter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occlusion rate	Occlusion rate of the great saphenous vein	One year after the treatment
Freedom from reflux	The absence of reflux in the treated great saphenous vein	One year after the treatment
Disease-specific quality of life	Quality of life as measured by the Aberdeen Varicose Veins Questionnaire	One year after the treatment
Occlusion rate	Occlusion rate of the great saphenous vein	three years after the treatment
Freedom from reflux	The absence of reflux in the treated great saphenous vein	three years after the treatment
Disease-specific quality of life	Quality of life as measured by the Aberdeen Varicose Veins Questionnaire	three years after the treatment
Occlusion rate	Occlusion rate of the great saphenous vein	five years after the treatment
Freedom from reflux	The absence of reflux in the treated great saphenous vein	five years after the treatment
Disease-specific quality of life	Quality of life as measured by the Aberdeen Varicose Veins Questionnaire	five years after the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peroperative and immediate postoperative pain	Perceived pain using Visual Analogue Scale (Range 0-10; 0=no pain; 2=Mild pain, 4=Nagging, uncomfortable pain; 6= Miserable pain; 8=Horrible pain; 10=worst possible, unbearable pain)	During the procedure, immediately after, and at one week after the treatment
Sick leave	Number of sick leave days necessary after the treatment	During the immediate postoperative period up to one month
Pain medication	The amount and type of pain medication received during and after the treatment	During the immediate postoperative period up to one month
30-day occlusion rate	The occlusion rate of the treated great saphenous vein	30 days after the treatment
Complications	All complications (deep venous thrombosis, nerve injuries, infections etc) after the treatment	Up to five years after the treatment

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital

Publications and helpful links

General Publications

• Vahaaho S, Halmesmaki K, Mahmoud O, Alback A, Noronen K, Venermo M. Three-year results of a randomized controlled trial comparing mechanochemical and thermal ablation in the treatment of insufficient great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2021 May;9(3):652-659. doi: 10.1016/j.jvsv.2020.08.007. Epub 2020 Aug 12. Erratum In: J Vasc Surg Venous Lymphat Disord. 2022 Jul;10(4):981.
• Vahaaho S, Mahmoud O, Halmesmaki K, Alback A, Noronen K, Vikatmaa P, Aho P, Venermo M. Randomized clinical trial of mechanochemical and endovenous thermal ablation of great saphenous varicose veins. Br J Surg. 2019 Apr;106(5):548-554. doi: 10.1002/bjs.11158.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2014
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Thermal ablation; Great saphenous vein; Mechanochemical ablation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: Clarivein RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes