MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins
- Conditions
- Greater Saphenous Vein Injury
- Interventions
- Procedure: Radiofrequency ablation (RFA)Device: Mechanochemical Endovenous Ablation (MOCA)
- Registration Number
- NCT01936168
- Lead Sponsor
- Rijnstate Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 213
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RFA Radiofrequency ablation (RFA) Radiofrequency Ablation (RFA) MOCA Mechanochemical Endovenous Ablation (MOCA) Mechanochemical Endovenous Ablation (MOCA)
- Primary Outcome Measures
Name Time Method Occlusion rate up to 5 years Occlusion rates between treatments will be compared at mentioned time points (both technical and clinical success)
- Secondary Outcome Measures
Name Time Method Procedure duration 30 days The duration of the procedures will be compared
Health status 1 year, 5 years 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.
Complications 30 days Complication at day 30 will be compared between treatments.
Post procedural pain score two weeks Pain during the the first two weeks after the procedure will be compared between treatments using the VAS score
Disease related quality of life 1 year, 5 years 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.
Per-procedural pain score two weeks Pain during the procedure will be compared between treatments using the VAS score
Costs of both treatments 1 year The total costs of both treatments will be compared
Trial Locations
- Locations (5)
Rijnstate Hospital
🇳🇱Arnhem, Gelderland, Netherlands
OLVG
🇳🇱Amsterdam, Netherlands
BovenIJ Hospital
🇳🇱Amsterdam, Netherlands
UMCG
🇳🇱Groningen, Netherlands
St. Antonius Hospital
🇳🇱Nieuwegein, Netherlands