MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins (MARADONA)

Mechanochemical Endovenous Ablation (MOCA) Versus RADiofrequeNcy Ablation (RFA) in the Treatment of Primary Great Saphenous Varicose Veins: a Multicentre Randomized Trial

The newly developed Mechanochemical Endovenous Ablation (MOCA) device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. Heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. Previously we showed that endovenous MOCA, using polidocanol, is feasible and safe in the treatment of great spahenous vein (GSV) incompetence. However, larger studies with a prolonged follow-up to prove the efficacy of this technique in terms of obliteration rates are lacking. This randomized trial was designed to compare occlusion rate, post-operative pain and complications between radiofrequency ablation (RFA: the current treatment for GSV incompetence) en MOCA.

Study Overview

• Status: Completed
• Conditions: Greater Saphenous Vein Injury
• Intervention / Treatment: Procedure: Radiofrequency ablation (RFA); Device: Mechanochemical Endovenous Ablation (MOCA)

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • OLVG
  • Amsterdam, Netherlands
    • BovenIJ hospital
  • Groningen, Netherlands
    • UMCG
  • Nieuwegein, Netherlands
    • St. Antonius Hospital
  • Gelderland
    • Arnhem, Gelderland, Netherlands
      • Rijnstate Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Insufficiency of the GSV
• Signed informed consent
• Patient willing to participate in follow-up scheme
• Age > 18 years
• Ultrasound criteria for endovenous treatment have been met:
• Diameter GSV between 3-12 mm
• No thrombus in the to be treated segment of the GSV

Exclusion Criteria:

• Patient not able to give informed consent
• Patient unable to present at follow-up visits
• Other treatment is more suitable
• Pregnancy and breast feeding
• Known allergy/ contra-indication for sclerotherapy
• Previous ipsilateral surgical treatment of varicose veins
• Deep venous thrombosis or lung emboli in medical history
• Anticoagulant therapy
• C5-C6 varices
• Immobilization
• Fontaine II or IV peripheral arterial disease
• Severe kidney function decline (GFS < 30 mL/min)
• Coagulation disorder or increased risk for thrombo-embolic complications(hemofilie A or B, v. Willebrand disease, Glanzmann disease, Factor VII-deficiency, idiopatic thrombocytopenic purpura, Factor V Leiden)
• Liver diseases accompanied by changes in blood coagulation, livver cirrhosis

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RFA; Radiofrequency Ablation (RFA)	Procedure: Radiofrequency ablation (RFA); Radiofrequency ablation (RFA)for treatment of great saphenous vein incompetence; Other Names: (RFA)
Experimental: MOCA; Mechanochemical Endovenous Ablation (MOCA)	Device: Mechanochemical Endovenous Ablation (MOCA); Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence; Other Names: (MOCA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occlusion rate	Occlusion rates between treatments will be compared at mentioned time points (both technical and clinical success)	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Per-procedural pain score	Pain during the procedure will be compared between treatments using the VAS score	two weeks
Complications	Complication at day 30 will be compared between treatments.	30 days
Procedure duration	The duration of the procedures will be compared	30 days
Costs of both treatments	The total costs of both treatments will be compared	1 year
Health status	Using the RAND 36-Item short From Health Survey (SF36) the general health status will be compared between treatments at various time points as specified by the protocol.	1 year, 5 years
Post procedural pain score	Pain during the the first two weeks after the procedure will be compared between treatments using the VAS score	two weeks
Disease related quality of life	Using the Aberdeen Varicose Vein Questionnaire (AVVQ)the disease related quality of life will be compared between treatments at various time points as specified by the protocol.	1 year, 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time	Time until daily activities and or work can be resumed (measured in days)	30 days

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Collaborators: St. Antonius Hospital; BovenIJ Hospital; OLVG
• Investigators: Principal Investigator: MMPJ Reijnen, MD, Rijnstate Hospital Arnhem

Publications and helpful links

General Publications

• van Eekeren RR, Boersma D, Elias S, Holewijn S, Werson DA, de Vries JP, Reijnen MM. Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study. J Endovasc Ther. 2011 Jun;18(3):328-34. doi: 10.1583/11-3394.1.
• Boersma D, van Eekeren RR, Werson DA, van der Waal RI, Reijnen MM, de Vries JP. Mechanochemical endovenous ablation of small saphenous vein insufficiency using the ClariVein((R)) device: one-year results of a prospective series. Eur J Vasc Endovasc Surg. 2013 Mar;45(3):299-303. doi: 10.1016/j.ejvs.2012.12.004. Epub 2013 Jan 9.
• van Eekeren RR, Boersma D, Konijn V, de Vries JP, Reijnen MM. Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg. 2013 Feb;57(2):445-50. doi: 10.1016/j.jvs.2012.07.049. Epub 2012 Nov 8.
• van Eekeren RR, Boersma D, de Vries JP, Reijnen MM. [Endovenous mechanochemical ablation for varicose veins--a new endovenous technique without tumescent anaesthesia]. Ned Tijdschr Geneeskd. 2011;155(33):A3177. Dutch.
• Holewijn S, van Eekeren RRJP, Vahl A, de Vries JPPM, Reijnen MMPJ; MARADONA study group. Two-year results of a multicenter randomized controlled trial comparing Mechanochemical endovenous Ablation to RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA trial). J Vasc Surg Venous Lymphat Disord. 2019 May;7(3):364-374. doi: 10.1016/j.jvsv.2018.12.014.
• van Eekeren RR, Boersma D, Holewijn S, Vahl A, de Vries JP, Zeebregts CJ, Reijnen MM. Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA): study protocol for a randomized controlled trial. Trials. 2014 Apr 11;15:121. doi: 10.1186/1745-6215-15-121.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: September 2, 2013
• First Submitted That Met QC Criteria: September 4, 2013
• First Posted (Estimate): September 5, 2013

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Treatment; Great Saphenous Vein; GSV; Primary Varicose Veins
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: 839-130312

Plan for Individual participant data (IPD)

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