Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With Flebogrif in Patients With Great Saphenous Vein Insufficiency

Inclusion Criteria

• •1. Signing the Informed Consent Form by the patient found eligible for the treatment with the mechanochemical method
• •2. The patient declares willingness to participate in the study and in the monitoring visits envisaged in the study protocol
• •3. A patient with diagnosed varicose veins and diagnosed great saphenous vein (GSV) insufficiency confirmed by ultrasound (CEAP class C2-C6)
• •4. Favourable anatomy enabling the introduction of the Flebogrif® guidewire/catheter and positioning of its top part at the dedicated site (2-3 cm below SFJ)
• •5. Diameter of the treated vein of 4-10 mm
• •6. No data or no history indicating an allergy to the sclerosing chemicals used in the mechanochemical method (polidocanol), on the basis of the information obtained from the patient and the available medical records
• •7. No clinical symptoms indicating (chronic, critical) lower limb ischaemia precluding the use of compression, on the basis of a physical examination or, in unclear cases, of a Doppler ultrasound examination
• •8. No medical information or no history of coagulation system dysfunction of the type of thrombophilia or bleeding diatheses
• •9. No cutaneous lesions (purulent, bullous) within the limb found eligible for treatment with the mechanochemical method
• •10. No clinical data indicating recent thrombosis within the deep vein system
• •11. No clinical data on diabetes with vascular complications
• •12. No clinical data indicating an active neoplastic process