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

NCT04558957 | Completed

• 1 other identifier: POLFLEB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Occlusion rate

  1, 6, 12, 18, 24 months

• Number of Participants with no reflux in treated segment of the vein

  1, 3, 6, 12, 18, 24 months

• Change in quality of life by Aberdeen Varicose Vein Questionnaire

  12 and 24 months

• Clinical success - changes in rVCSS

  12 and 24 months

• Assessment of pain during the procedure

  During procedure

Study Arms (1)

FLEBOGRIF

EXPERIMENTAL

Interventions will be performed using Flebogrif catheter.

Device: FLEBOGRIF

Interventions

FLEBOGRIF DEVICE

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

FLEBOGRIF

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Balton Sp.zo.o.: lead
• KCRI: collaborator

Study Sites (4)

Centrum Chirurgii i Stomatologii Jaworuccy Sp. P.

Gorzów Wielkopolski, 66-400, Poland

Location

Centrum Medyczne Angelius Provita; Europejskie Centrum Flebologii

Katowice, 40-611, Poland

Location

Medyczne Centrum Nałęczów sp. z o.o.

Lublin, 20-950, Poland

Location

Klinika Dorobisz

Wroclaw, 54-130, Poland

Location

MeSH Terms

Conditions

Blindness, Cortical

Condition Hierarchy (Ancestors)

Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 22, 2020
• Study Start: August 8, 2019
• Primary Completion: August 12, 2021
• Study Completion: April 28, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

PL (4)