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

NCT ID: NCT04558957

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-08
• Study Completion Date: 2023-04-28

Brief 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.

Conditions

Chronic Venous Insufficiency, CVI

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FLEBOGRIF

Interventions will be performed using Flebogrif catheter.

Group Type: EXPERIMENTAL

FLEBOGRIF

Intervention Type: DEVICE

The catheter is a device dedicated to mechano-chemical ablation of insufficient veins of the superficial system.

Interventions

FLEBOGRIF

The catheter is a device dedicated to mechano-chemical ablation of insufficient veins of the superficial system.

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KCRI

OTHER

Sponsor Role: collaborator

Balton Sp.zo.o.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centrum Chirurgii i Stomatologii Jaworuccy Sp. P.

Gorzów Wielkopolski, , Poland

Centrum Medyczne Angelius Provita; Europejskie Centrum Flebologii

Katowice, , Poland

Medyczne Centrum Nałęczów sp. z o.o.

Lublin, , Poland

Klinika Dorobisz

Wroclaw, , Poland

Countries

Poland

Other Identifiers

POLFLEB

Identifier Type: -

Identifier Source: org_study_id