Mechanochemical Endovenous ablation (MOCATM) versus radiofrequency ablation (RFA) in the treatment of primary Small Saphenous vein Insufficiency: a multicentre randomized trial

Completed

Conditions: varicose veins
venous insufficiency
10057165

Registration Number: NL-OMON40762

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

1. Primary SSV incompetence
2. Symptomatic varicose veins, C1-C5
3. Duplex ultrasound criteria meet criteria for general endovenous treatment: diameter of small saphenous vein > 3 mm and < 12 mm, non-tortuous
4. Signed informed consent
5. Patient is willing to participate in follow up
6. Age> 18 year and < 80 year

Exclusion Criteria

1. Patient is incapable of informed consent
2. Pregnancy and lactation
3. C6 varicose veins
4. Pervious surgical or endovenous treatment of the affected vein
5. History of deep venous thrombosis in the affected leg
6. Oral anticoagulants
7. Contraindication or known allergy to sclerosans
8. Immobilization
9. Coagulation disorders or increased risk of thrombo-embolic complications: known coagulation disorders as hemophilia A, hemophilia B, Von Willebrandt disease, Glanzmann disease, factor VII-deficiency, idiopathic trombocytopenic purpura, factor V Leiden, deep venous thrombosis or pulmonary embolism in medical history
10. Fontaine III of IV peripheral arterial disease
11. Severe renal insufficiency: known glomerular filtration rate < 30 mL/min
12. Liver disease, associated with changes in coagulation, anemnestic evidence of bleeding as epistaxis and spontaneous hematoma, liver cirrhosis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is anatomical success at 1 year follow-up. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters<br /><br>- Pain during and after procedure<br /><br>- Initial technical success<br /><br>- Clinical success (CEAP, VCSS, QoL)<br /><br>- Complications<br /><br>- Length of procedure</p><br>