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

Balton Sp.zo.o.200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Chronic Venous Insufficiency, CVI

Interventions

FLEBOGRIF

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Study 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 Study exclusion criteria: 1. Recent deep vein thrombosis or occlusion 2. Congenital disorders with associated occlusion of deep system veins 3. Pregnancy and breast-feeding 4. Lower limb ischaemia 5. Severe lymphatic oedema 6. Bleeding diatheses 7. Documented allergic reaction to sclerosing chemicals used in mechanochemical vein ablation 8. Purulent dermatoses affecting the limb found eligible for treatment with mechanochemical vein ablation 9. Previous procedures on insufficiency veins of the superficial system 10. Acute infection 11. History of great saphenous vein thrombosis 12. End-stage kidney disease

Outcomes

Primary Outcomes

Primary efficacy endpoint: Occlusion rate

Primary efficacy endpoint: Occlusion rate of the great saphenous vein in the treated segment at 3 months

Time frame: 3 months

Primary safety endpoint: Rate of SAE

Primary safety endpoint: Rate of serious adverse events within 30 days after the procedure

Time frame: 30 days after the procedure

Secondary Outcomes

Occlusion rate

Occlusion rate of the great saphenous vein at 1, 6, 12, 18 and 24 months

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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)

Time frame: 0-7 days after procedure

Period needed to resume normal activities

Time frame: up to 2 years after the treatment

Period needed to return to work (sick leave period)

Time frame: up to 2 years after the treatment

Complications rate

Complications rate including deep vein thrombosis, nerve damage, infections, etc.

Time frame: up to 2 years after the treatment

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

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes