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

Rijnstate Hospital

Status

Completed

Conditions

Greater Saphenous Vein Injury

Treatments

Device: Mechanochemical Endovenous Ablation (MOCA)

Procedure: Radiofrequency ablation (RFA)

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT01936168

839-130312

Details and patient eligibility

About

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.

Enrollment

213 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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