Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With Flebogrif in Pa… (NCT04558957) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With Flebogrif in Patients With Great Saphenous Vein Insufficiency
Poland200 participantsStarted 2019-08-08
Plain-language summary
The objective of the study is to collect clinical data of patients in whom Flebogrif® will have been used for mechanochemical ablation of incompetent veins in the follow-up period, as related to the safety, clinical effectiveness, properties and advantages of Flebogrif®.
The proposed study is a prospective, multi-centre clinical trial assessing the safety, efficacy and quality of Flebogrif® in a population of patients with the incompetent great saphenous vein, who require surgical treatment.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
âś“. Signing the Informed Consent Form by the patient found eligible for the treatment with the mechanochemical method
âś“. The patient declares willingness to participate in the study and in the monitoring visits envisaged in the study protocol
âś“. A patient with diagnosed varicose veins and diagnosed great saphenous vein (GSV) insufficiency confirmed by ultrasound (CEAP class C2-C6)
✓. 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)
âś“. Diameter of the treated vein of 4-10 mm
âś“. 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
âś“. 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
âś“. No medical information or no history of coagulation system dysfunction of the type of thrombophilia or bleeding diatheses
Exclusion criteria
âś•. Recent deep vein thrombosis or occlusion
âś•. Congenital disorders with associated occlusion of deep system veins