This trial is active, not recruiting.

Condition greater saphenous vein injury
Treatments mechanochemical endovenous ablation (moca), radiofrequency ablation (rfa)
Sponsor Rijnstate Hospital
Collaborator St. Antonius Hospital
Start date October 2012
End date December 2019
Trial size 460 participants
Trial identifier NCT01936168, 839-130312


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Radiofrequency Ablation (RFA)
radiofrequency ablation (rfa) (RFA)
Radiofrequency ablation (RFA)for treatment of great saphenous vein incompetence
Mechanochemical Endovenous Ablation (MOCA)
mechanochemical endovenous ablation (moca) (MOCA)
Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence

Primary Outcomes

Occlusion rate
time frame: up to 5 years

Secondary Outcomes

Per-procedural pain score
time frame: two weeks
time frame: 30 days
Procedure duration
time frame: 30 days
Costs of both treatments
time frame: 1 year
Health status
time frame: 1 year, 5 years
Post procedural pain score
time frame: two weeks
Disease related quality of life
time frame: 1 year, 5 years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Mechanochemical Endovenous Ablation (MOCA) Versus RADiofrequeNcy Ablation (RFA) in the Treatment of Primary Great Saphenous Varicose Veins: a Multicentre Randomized Trial
Principal investigator MMPJ Reijnen, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Rijnstate Hospital.