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

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

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 Overview

• Status: Completed
• Conditions: Chronic Venous Insufficiency, CVI
• Intervention / Treatment: Device: FLEBOGRIF

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elżbieta Sojka; Phone Number: +48 22 597 44 43; Email: elzbieta.sojka@balton.pl

Study Locations

• Poland
  • Gorzów Wielkopolski, Poland, 66-400
    • Centrum Chirurgii i Stomatologii Jaworuccy Sp. P.
  • Katowice, Poland, 40-611
    • Centrum Medyczne Angelius Provita; Europejskie Centrum Flebologii
  • Lublin, Poland, 20-950
    • Medyczne Centrum Nałęczów sp. z o.o.
  • Wrocław, Poland, 54-130
    • Klinika Dorobisz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Balton Sp.zo.o.
• Collaborators: KCRI

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2019
• Primary Completion (Actual): August 12, 2021
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: POLFLEB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No