great saphenous vein incompetence varicose
Conditions
Interventions
ClariVein liquid Polidocanol (2%,3%) procedure:
The patient will be examined by ultrasound to identify the GSV at the knee
level. This will be done while the patient is standing. After the GSV is
id
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
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 < 18 years and or incompetent. 2) Life expectancy of less than 6 months 3) Previous surgery for GSV incompetence 4) Occlusion of deep venous system 5) Pregnancy 6) No informed consent 7) Extreme obesity: BMI> 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 diameter 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 25,5cm of the treated 30cm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean VCSS change (evaluated at mentioned time points). Pain score during procedure (VAS) Two weeks post-preocedure pain score (VAS) Health status (using the SF36 the general health status will be evaluated at mentioned time points). Disease related quality of life (using the AVVQ, the quality of life related to the disease will be evaluated at mentioned time points). Adverse events Patient satisfaction measured in separate scores. | — |
Countries
Netherlands
Outcome results
None listed