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

Balton

Status: Completed

Conditions: Chronic Venous Insufficiency, CVI

Treatments: Device: FLEBOGRIF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04558957

POLFLEB

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

FLEBOGRIF

Experimental group

Description:

Interventions will be performed using Flebogrif catheter.

Treatment:

Device: FLEBOGRIF