varicose veins venous insufficiency
Conditions
Interventions
"Experimental"
- Mechano-chemical ablation of insufficient SSV
"Control"
-Radiofrequency ablation of insufficient SSV
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 18 year and
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is anatomical success at 1 year follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters - Pain during and after procedure - Initial technical success - Clinical success (CEAP, VCSS, QoL) - Complications - Length of procedure | — |
Countries
Netherlands
Outcome results
None listed