Incompetence of the great saphenous vein Varicose veins ClariVein Minimal invasive
Conditions
Interventions
The procedure will be identical for every patient, except for the dosage and form of the chemical component. The patient will be examined by ultrasound to identify the GSV at the knee level. This will
Sponsors
academisch ziekenhuis maastricht (azM).
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who are first time treated for incompetence of the VSM, proven with duplex ultrasound examination; 2. CEAP classification C2-C4; 3. All patients with informed consent.
Exclusion criteria
Exclusion criteria: 1. Age 40; 8. Very tortuous pace of GSV which bends at an angle of >90 º or more twists follow each other; 9. Allergy or contraindication to Polidocanol; 10. GSV bigger than 12mm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our primary endpoint is the anatomical success rate of the treated GSV after 6 months, defined as occlusion confirmed by ultrasound of at least 85% which correlates to 24,5cm of the treated 30cm. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean VCSS change (evaluated at mentioned time points); 2. Pain score during procedure (VAS); 3. Two weeks post-preocedure pain score (VAS); 4. Health status (using the SF36 the general health status will be evaluated at mentioned time points); 5. Disease related quality of life (using the AVVQ, the quality of life related to the disease will be evaluated at mentioned time points); 6. Adverse events; 7. Patient satisfaction measured in separate scores. | — |
Contacts
Public ContactY.L. Lam
Y.L. Lam MD, P. Debyelaan 25
Outcome results
None listed