Greater Saphenous Vein Injury
Conditions
Keywords
GSV, Primary Varicose Veins, Great Saphenous Vein, Treatment
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.
Interventions
DEVICEMechanochemical Endovenous Ablation (MOCA)
Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence
PROCEDURERadiofrequency ablation (RFA)
Radiofrequency ablation (RFA)for treatment of great saphenous vein incompetence
Sponsors
St. Antonius Hospital
OLVG
BovenIJ Hospital
Rijnstate Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occlusion rate | up to 5 years | Occlusion rates between treatments will be compared at mentioned time points (both technical and clinical success) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Per-procedural pain score | two weeks | Pain during the procedure will be compared between treatments using the VAS score |
| Complications | 30 days | Complication at day 30 will be compared between treatments. |
| 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. |
| 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. |
| Costs of both treatments | 1 year | The total costs of both treatments will be compared |
Other
| Measure | Time frame | Description |
|---|---|---|
| Recovery time | 30 days | Time until daily activities and or work can be resumed (measured in days) |
Countries
Netherlands
Outcome results
None listed