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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Multi-centre Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With the Use of Flebogrif in Patients With Great Saphenous Vein Insufficiency

Conditions
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Chronic Venous Insufficiency, CVI

Intervention / Treatment
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* Device: FLEBOGRIF


Participation Criteria
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Eligibility Criteria
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Study inclusion criteria: Signing the Informed Consent Form by the patient found eligible for the treatment with the mechanochemical method The patient declares willingness to participate in the study and in the monitoring visits envisaged in the study protocol 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) Diameter of the treated vein of 4-10 mm 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 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 No medical information or no history of coagulation system dysfunction of the type of thrombophilia or bleeding diatheses No cutaneous lesions (purulent, bullous) within the limb found eligible for treatment with the mechanochemical method No clinical data indicating recent thrombosis within the deep vein system No clinical data on diabetes with vascular complications No clinical data indicating an active neoplastic process Study exclusion criteria: Recent deep vein thrombosis or occlusion Congenital disorders with associated occlusion of deep system veins Pregnancy and breast-feeding Lower limb ischaemia Severe lymphatic oedema Bleeding diatheses Documented allergic reaction to sclerosing chemicals used in mechanochemical vein ablation Purulent dermatoses affecting the limb found eligible for treatment with mechanochemical vein ablation Previous procedures on insufficiency veins of the superficial system Acute infection History of great saphenous vein thrombosis End-stage kidney disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLEBOGRIF<br>Interventions will be performed using Flebogrif catheter. | Device: FLEBOGRIF<br>* The catheter is a device dedicated to mechano-chemical ablation of insufficient veins of the superficial system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy endpoint: Occlusion rate | Primary efficacy endpoint: Occlusion rate of the great saphenous vein in the treated segment at 3 months | 3 months | 
| Primary safety endpoint: Rate of SAE | Primary safety endpoint: Rate of serious adverse events within 30 days after the procedure | 30 days after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion rate | Occlusion rate of the great saphenous vein at 1, 6, 12, 18 and 24 months | 1, 6, 12, 18, 24 months | 
| Number of Participants with no reflux in treated segment of the vein | Number of Participants with no reflux in the treated segment of the great saphenous vein at 1, 3, 6, 12, 18 and 24 months | 1, 3, 6, 12, 18, 24 months | 
| Change in quality of life by Aberdeen Varicose Vein Questionnaire | Change in quality of life measured with the use of the Aberdeen Varicose Vein Questionnaire at 12 and 24 months Scale score: 0-100; higher score = worse outcome. | 12 and 24 months | 
| Clinical success - changes in rVCSS | Clinical success, defined as change in rVCSS classification (Revised Venous Clinical Severity Score) after 12 and 24 months Scale score 0-30; higher score = worse outcome. | 12 and 24 months | 
| Assessment of pain during the procedure | Assessment of pain during the procedure (Visual Analogue Pain Scale, VAPS) ranging from 0 to 10. Pain assessed using the Visual Analogue Scale (range 0-10; 0 = no pain; 2 = mild pain, 4 = nagging, annoying pain; 6 = severe pain; 8 = very severe pain; 10 = unbearable pain). | During procedure | 
| Assessment of pain within 0-7 days after the procedure: Visual Analogue Scale | Assessment of pain within 0-7 days after the procedure (VAPS 0-10, daily assessment). Pain assessed using the Visual Analogue Scale (range 0-10; 0 = no pain; 2 = mild pain, 4 = nagging, annoying pain; 6 = severe pain; 8 = very severe pain; 10 = unbearable pain). | 0-7 days after procedure | 
| Assessment of the need for analgesic treatment | Assessment of the need for analgesic treatment after the procedure (0-7 days) | 0-7 days after procedure | 
| Period needed to resume normal activities | Period needed to resume normal activities | up to 2 years after the treatment | 
| Period needed to return to work (sick leave period) | Period needed to return to work (sick leave period) | up to 2 years after the treatment | 
| Complications rate | Complications rate including deep vein thrombosis, nerve damage, infections, etc. | up to 2 years after the treatment |